Safety practices for interventional pain procedures: Disc access/provocation discography, vertebral augmentation, and neurostimulation procedures

These safety practices have been developed to highlight the important elements in the safe performance of interventional pain procedures. Adherence to these practices will help decrease the risk of preventable complications. For additional information about the indications and technical aspects that yield improved treatment outcomes, refer to the IPSIS Technical Manual and Atlas of Interventional Pain and Spine Procedures.

1. Disc access/provocation discography

Ameet Nagpal, MD, MS, MEd, MBA; Fred DeFrancesch, MD; Kevin Martinez, MD; George Rappard, MD; Yakov Vorobeychik, MD, PhD.

1.1. Personnel

• •Only physicians trained in disc access technique and interpretation of provocation discography should perform this procedure.
• •Appropriately trained personnel are needed to operate the fluoroscopy unit or assist the physician.

1.2. Contraindications

1.2.1. Absolute

• •Uncooperative patient or inability to obtain informed consent
• •Inability to communicate pain level
• •Systemic infection or local infection within the procedure field
• •Allergy to medication(s) that cannot safely be omitted or mitigated by pre-treatment
• •Pregnancy
• •Hypertensive emergency/urgency
• •Central canal stenosis ≤10 mm (e.g., congenital, disc herniation, spondylosis) at the target level – cervical or thoracic only
• •Known esophageal diverticulum - cervical only
• •Anatomical derangements that compromise the safe and successful conduct of the procedure

1.2.2. Relative

• •Asymptomatic blood pressure >180/110
• •Uncorrected coagulopathy or known bleeding diathesis
• •Use of antithrombotic agents
• •Significant psychiatric or psychological comorbidity
• •Immunosuppression

1.3. Antithrombotics and bleeding disorders

• •The decision to continue or how to temporarily discontinue anticoagulation/antiplatelet (AC/AP) therapy must take into account potential complications in each scenario.
• •There is a quantifiable risk of life-threatening thrombotic events associated with discontinuation of therapeutic AC/AP agents for spine interventions.
• •The decision to temporarily discontinue AC/AP therapy and whether to employ a bridging strategy should include the patient and the physician prescribing the AC/AP therapy.
• •The bleeding risk is classified as presumed low-intermediate for discography procedures and is further dependent on the anatomical level, with cervical discography conferring a higher risk than thoracic discography and thoracic discography posing a higher bleeding risk than lumbar discography.

1.4. Procedural sedation

• •Sedation is not intrinsically necessary for provocation discography, but if employed in unique circumstances (e.g., movement disorder, cases of extreme anxiety, previous vasovagal response), the patient should remain able to communicate pain or other adverse sensations or events. Deep sedation and general anesthesia are contraindicated for provocation discography.
• •The use of sedation may alter diagnostic conclusions. If utilized, conscious sedation should be carefully titrated to allow optimal patient discernment of pain during disc provocation.
• •The use of analgesic (e.g., opioids) and anxiolytic medications will affect perceived pain and negatively alter diagnostic results.
• •The decision to use sedation for an appropriate indication should be made on a case-by-case basis. Patients should be advised during informed consent that procedural sedation is not necessary but elective.
• •If the physician performing the procedure decides that sedation is indicated, a separate healthcare provider must administer the medications and monitor the patient.
• •Resuscitation drugs, appropriate monitoring equipment, and oxygen must be available if sedation is utilized.

1.5. Safe, aseptic practices

• •
  Strict aseptic techniques should always be applied to the facility, patient, physician, assisting personnel, injectate/syringe, and other procedural materials. Examples include, but are not limited to:

  • o
    Skin prepared and draped as if for a surgical procedure
  • o
    All personnel in close proximity to the surgical field must wear a face mask, cap, sterile gown, and sterile gloves during the procedure.
  • o
    Placing a sterile cover over the image collector
  • o
    Use intradiscal and/or intravenous (IV) prophylactic antibiotics
  • o
    Disc puncture needle tips should, at no time, be touched regardless of gloving. Sterile gauze or another technique must be used for all needle tip manipulation (e.g., bending).
  • o
    Sterile single-use syringes and needles are required, and single-dose vials should be utilized when available.
  • o
    Acquisition, storage, and utilization of medications should adhere to relevant regulatory guidelines.

1.6. Imaging

• •Pre-procedure MRI or CT images should be reviewed by the physician.
• •Needle insertion should be performed with proper fluoroscopic technique.
• •The final needle tip position should be confirmed as close as possible to the center of the targeted disc using true AP and true lateral views before contrast medium injection.
• •The fluoroscopic technique should follow the ALARA (As Low As Reasonably Achievable) principles to minimize X-ray exposure for the patient and the healthcare team.
• •Gadolinium-based contrast media (GBCM) should be used with caution in interventional pain procedures and only when necessary. The clinical benefit of the interventional pain treatment should be weighed against the risk of catastrophic outcomes with intrathecal administration of even small amounts of GBCM, including acute neurotoxicity (confusion, acute agitation, reduced level of consciousness, visual and auditory hallucinations, seizures, severe spasticity), tachycardia, elevated blood pressure, vomiting, and respiratory failure. GBCM is not recommended for use in procedures where intrathecal access is possible. The risk of inadvertent intrathecal injection with discography is very low.
• •In procedures where intrathecal access is not possible, GBCM can be utilized. However, GBCM has a lower relative radiodensity compared to ICM, producing a contrast flow pattern that is less apparent on fluoroscopy. Regardless, the lowest necessary volume of GBCM should be utilized.

1.7. Discography procedure

• •IV catheter placement is necessary if sedation, IV antibiotics, or post-procedure IV analgesic administration is planned.

1.8. Post-procedure monitoring/follow-up

• •Patients should be monitored for an appropriate time following the procedure, depending upon the nature of the intervention and the agents utilized.
• •
  Provide detailed oral and written discharge instructions to patients that outline the following:

  • o
    restrictions and recommendations for the immediate post-procedure period
  • o
    potential common side effects that may occur immediately post-procedure and in the days following the procedure (e.g., pain at the injection site or increased index pain of a similar location and quality)
  • o
    symptoms that merit immediate medical attention (neurologic changes or severe pain).

    • ●
      Disc access/provocation discography carries a unique risk of discitis. Patients who report severe, prolonged worsening of cervical, thoracic, or low back pain or other signs of systemic infection should be evaluated to rule out discitis.
  • o
    timing for resumption of usual medications and anticoagulants if discontinued for the procedure
• •Ensure patients have a follow-up plan.

Sources

• Benzon HT, Maus TP, Kang HR, Provenzano DA, Bhatia A, Diehn F et al. The use of contrast agents in interventional pain procedures: A multispecialty and multisociety practice advisory on nephrogenic systemic fibrosis, gadolinium deposition in the brain, encephalopathy after unintentional intrathecal gadolinium injection, and hypersensitivity reactions. Anesth Analg 2021; 133(2):535–552.

• Bogduk N, Aprill C, Derby R. Lumbar discogenic pain: state of the art review. Pain Medicine 2013; 14:813–836.

• International Spine Intervention Society. Sedation. In: Bogduk N (ed), Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Intravenous lines. In: Bogduk N (ed), Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Records. In: Bogduk N (ed) Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Anticoagulants. In: Bogduk N (ed), Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Cervical disc stimulation (provocation discography). In: Bogduk N (ed) Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Thoracic disc access. In: Bogduk N (ed), Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• International Spine Intervention Society. Lumbar intervertebral disc access. In: Bogduk N (ed), Practice Guidelines for Spinal Diagnostic and Treatment Procedures, 2nd edn. International Spine Intervention Society, San Francisco, 2013.

• Landers M. Discography (Part B) Intervertebral disc access and stimulation: lumbar, thoracic, and cervical. In: Lennard T, Walkowski S, Singla A, Vivian D. (eds), Pain Procedures in Clinical Practice 3rd ed. Elsevier Sanders, Philadelphia, 2011.

• Maus TP, Cohen I, McCormick ZL, Schneider BJ, Smith CC, Stojanovic MP, Waring PH (Eds). Technical Manual and Atlas of Interventional Pain and Spine Procedures. International Pain and Spine Intervention Society; 2024.

2. Vertebral augmentation (kyphoplasty or vertebroplasty)

Ameet Nagpal, MD, MS, MEd, MBA; D. Scott Kreiner, MD; Jatinder Gill, MD; Yakov Vorobeychik, MD, PhD.

2.1. Personnel

• •Only physicians trained in vertebral augmentation should perform this procedure.
• •Appropriately trained personnel are needed to operate the fluoroscopy unit or assist the physician.

2.2. Contraindications

2.2.1. Absolute

• •An active systemic or localized infection within the procedural field
• •Uncooperative patient or inability to obtain informed consent
• •Allergy to medication(s) that cannot safely be mitigated by pre-treatment
• •Uncorrectable coagulopathy
• •Hypotensive emergency/urgency
• •Anatomical derangements that compromise the safe and successful conduct of the procedure

2.2.2. Relative

• •Pregnancy: Vertebral augmentation (VA) is usually contraindicated. There may be exceptional situations in which benefits could prevail over risks. Radiation exposure to the fetus should be minimized.
• •Coagulopathy [normalize/correct clotting function (INR <1.5)]: The risk of bleeding should be balanced against the complications associated with bed rest. Caution in patients with thrombocytopenia (platelets less than 100,000/μl).
• •Asymptomatic blood pressure >180/110
• •Fracture retropulsion/canal compromise: Bony retropulsion is generally not considered a contraindication unless there is a neurologic deficit. VA may worsen any neurologic compromise and should only be considered in unusual circumstances. A CT scan may determine the integrity of the posterior wall before the procedure. If the fracture is causing spinal cord compression and/or neurologic deficit, then surgical decompression and stabilization are indicated. In this scenario, VA may worsen the neurologic compromise and should only be considered in unusual circumstances.
• •The presence of an unstable spinal fracture, depending on the degree of instability and fracture level: Surgical intervention is likely needed to address instability and may be performed during the same session as vertebral augmentation.
• •Allergies to bone cement or other agents used in the procedure, depending on the severity of allergy: If prior reactions were not associated with anaphylaxis, the risk of an allergic reaction may be mitigated by pretreatment with antihistamines and steroids. The physician may also choose a different fill material.
• •Inadequate fluoroscopic visualization of bony structures secondary to severe osteoporosis or malignant process: CT guidance may be helpful.
• •Metastasis or primary tumor extending into the epidural space

2.3. Antithrombotics and bleeding risk

• •The decision to continue or how to temporarily discontinue anticoagulation/antiplatelet (AC/AP) therapy must take into account potential complications in each scenario.
• •There is a quantifiable risk of life-threatening thrombotic events associated with discontinuation of therapeutic AC/AP agents for spine interventions.
• •The decision to temporarily discontinue AC/AP therapy and whether to employ a bridging strategy should include the patient and the physician prescribing the AC/AP therapy.
• •The bleeding risk is classified as intermediate-high for vertebral augmentation procedures.

2.4. Procedural sedation

• •VA may be performed under local anesthesia alone; however, given the associated procedural pain, these cases (especially kyphoplasty) are often performed under conscious sedation or monitored anesthesia care (MAC).
• •General anesthesia may also be used at the discretion of the anesthesia team and the performing physician.
• •The decision to use sedation should be made on a case-by-case basis.
• •If the physician performing the procedure decides that sedation is indicated, a separate healthcare provider must administer the medications and monitor the patient.
• •Resuscitation drugs, appropriate monitoring equipment, and oxygen must be available if sedation is utilized.

2.5. Antibiotic prophylaxis

• •Because of the nature of the fracture and the frailty of patients who typically develop fractures requiring treatment, antibiotic prophylaxis is recommended to decrease the risk of perioperative infection.
• •Preoperative antibiotic administration: 1 dose within 30–120 min before incision/start of the procedure (cephalosporins such as cefazolin 1–3 g or cefuroxime 1.5 g intravenously. If allergic to beta-lactams, give clindamycin 600 mg. If the patient is colonized with MRSA, use vancomycin 1 g)
• •An additional dose is indicated if the procedure duration exceeds 4 h.

2.6. Safe, aseptic practices

• •
  Strict aseptic technique should always be applied to the facility, patient, physician, assisting personnel, injectate/syringe, and other procedural materials. Examples include, but are not limited to:

  • o
    Skin overlying the target region should be prepared for an aseptic procedure, preferably using chlorhexidine in alcohol. The area should then be draped to create a sterile field.
  • o
    Barriers, including sterile gloves, sterile gowns, caps, and masks, should be utilized during the procedure.
  • o
    Sterile equipment should be utilized, including a sterile C-arm cover.
  • o
    Sterile single-use syringes and needles are required, and single-dose vials should be utilized when available.
  • o
    Acquisition, storage, and utilization of medications should adhere to relevant regulatory guidelines.

2.7. Imaging

• •Appropriate imaging (MRI, CT, or bone scan) or recent prior study comparison is highly recommended to confirm a recent or unhealed fracture.
• •Use of image guidance and live fluoroscopy is critical for appropriate needle placement and monitoring polymethylmethacrylate (PMMA) placement.
• •Fluoroscopic guidance has been used in the primary literature; if alternative imaging guidance is to be used (e.g., CT), it must be utilized to exclude vascular uptake or flow of PMMA into other areas outside the vertebral body.
• •The fluoroscopic technique should follow the ALARA (As Low As Reasonably Achievable) protocols to minimize X-ray exposure for the patient and the healthcare team.

2.8. Injections

• •The ultimate choice of approach or technique (vertebroplasty vs. kyphoplasty vs. other augmentation technique) should be made by the treating physician by balancing the potential risks and benefits of each technique for each patient.
• •When a transpedicular approach is used, the needle should be advanced with AP or oblique viewing to allow visualization of the medial border of the pedicle. The needle should not violate the medial border of the pedicle. The needle should not be advanced in lateral view until it has crossed the posterior margin of the vertebral body in lateral views.
• •When an extrapedicular or parapedicular approach is required, the physician should carefully review available cross-sectional imaging to ensure an extrapedicular approach will not violate venous or arterial structures which lay lateral to the pedicle.
• •
  Most reported complications are related to PMMA leakage or placement in unintended structures. Such complications include spinal cord injuries from leakage into the spinal canal and pulmonary emboli of PMMA. Sufficient time should be allowed for the PMMA to cure and become sufficiently viscous before administration to minimize the risk of these complications. In addition:

  • o
    If PMMA is seen filling a tubular structure, the injection should be stopped because placement is likely intravenous.
  • o
    Injection should be stopped when PMMA is seen approaching the posterior margin of the vertebral body (within approximately 5 mm) to avoid PMMA leaking into the spinal canal.
• •When treating a fracture due to malignancy, an approach minimizing needle trajectory through the tumor is preferred to reduce the risk of seeding the tumor. For example, if a tumor is present in one pedicle, a transpedicular approach on the opposite side or a parapedicular approach is preferred.

2.9. Post-procedure monitoring/follow-up

• •Patients should be monitored for an appropriate time following the procedure, depending upon the nature of the intervention and the agents utilized.
• •
  Provide detailed oral and written discharge instructions to patients that outline the following:

  • o
    restrictions and recommendations for the immediate post-procedure period
  • o
    potential common side effects that may occur immediately post-procedure and in the days following the procedure
  • o
    symptoms that merit immediate medical attention
  • o
    timing for resumption of usual medications and anticoagulants if discontinued for the procedure
• •Ensure patients have a follow-up plan.

Sources

• American College of Radiology. ACR–ASNR–ASSR–SIR–SNIS Practice Parameter for the Performance of Vertebral Augmentation. Available at: https://www.acr.org/-/media/ACR/Files/Practice-Parameters/VerebralAug.pdf. Accessed December 21, 2018.

• Hirsch JA, Beall DP, Chambers MR et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. The Spine Journal: Official Journal of the North American Spine Society. 2018.

• Maus TP, Cohen I, McCormick ZL, Schneider BJ, Smith CC, Stojanovic MP, Waring PH (Eds). Technical Manual and Atlas of Interventional Pain and Spine Procedures. International Pain and Spine Intervention Society; 2024.

3. Spinal cord and dorsal root ganglion stimulation (trial and permanent implantation)

Ameet Nagpal, MD, MS, MEd, MBA; Yakov Vorobeychik, MD, PhD.

3.1. Personnel

• •Only physicians trained in spinal cord stimulation (SCS) and/or dorsal root ganglion stimulation (DRGS) should perform these procedures.
• •Appropriately trained personnel are needed to operate the fluoroscopy unit or assist the physician.

3.2. Contraindications

3.2.1. Absolute

• •An active infection
• •Uncooperative patient or inability to obtain informed consent
• •Allergy to medication(s) that cannot safely be omitted or mitigated by pre-treatment
• •Hypertensive emergency/urgency
• •Pregnancy
• •Coagulopathy: For SCS/DRGS lead placement and removal, coagulopathy increases the risk of epidural hematoma formation with consequent neurologic compromise.
• •Central spinal canal (severe narrowing or obliteration of the posterior epidural space) or laminectomy that includes the levels from the planned epidural access to the final lead tip position
• •Severe foraminal stenosis for placement of DRGS
• •Anatomical derangements that compromise the safe and successful conduct of the procedure

3.2.2. Relative

• •Asymptomatic blood pressure >180/110
• •Spinal surgery at the levels where stimulator lead advancement is anticipated for SCS and DRGS
• •Immunosuppression
• •Certain occupations and hobbies may increase the risk of lead migration or the potential for interference with or hazard associated with SCS or DRGS.
• •Need for future MRI depending on SCS/DRGS technology and MRI compatibility
• •SCS/DRGS may be safely performed in the presence of a pacemaker or automated implantable cardioverter defibrillator. In this scenario, collaboration with the cardiologist or electrophysiologist is advised.

3.3. Antithrombotics and bleeding disorders

• •The decision to continue or how to temporarily discontinue anticoagulation/antiplatelet (AC/AP) therapy must take into account potential complications in each scenario.
• •There is a quantifiable risk of life-threatening thrombotic events associated with discontinuation of therapeutic AC/AP agents for spine interventions.
• •The decision to temporarily discontinue AC/AP therapy and whether to employ a bridging strategy should include the patient and the physician prescribing the AC/AP therapy.
• •Consistent with the IPSIS Technical Manual and Atlas of Interventional Pain and Spine Procedures, the bleeding risk is classified as intermediate-high for SCS/DRGS procedures.

3.4. Procedural sedation

• •In certain cases, moderate sedation or monitored anesthesia care (MAC) may be needed during trial lead placement for SCS and DRGS. The use of sedation needs to be assessed and discussed on a case-by-case basis.
• •Spinal cord injury (cord transgression) during interlaminar epidural access has been associated with deep sedation or general anesthesia, which is unnecessary for interlaminar access and should not be used. If moderate sedation is used for interlaminar access, the patient must always remain conscious and be able to communicate.
• •Resuscitation drugs, appropriate monitoring equipment, and oxygen must be available if sedation is utilized.

3.5. Antibiotic prophylaxis

• •Optimization of hyperglycemia in diabetic patients decreases the risk of infection. While no specific hemoglobin A1C and/or point-of-care blood glucose levels are known to prevent infection, some data suggest that hemoglobin A1C levels above 8.0 % and FSBG levels above 200 increase the possibility of infection.
• •Cessation of nicotine products for 30 days has been shown to decrease the risk of infection.
• •Preoperative antibiotic administration: 1 dose within 30–120 min before incision/start of the procedure (cephalosporins such as cefazolin 1–3 g or cefuroxime 1.5 g intravenously. If allergic to beta-lactams, give clindamycin 600 mg. If the patient is colonized with MRSA, use vancomycin 1 g)
• •An additional dose is indicated if the procedure duration exceeds 4 h.

3.6. Safe, aseptic practices

• •
  Strict aseptic technique should always be applied to the facility, patient, physician, assisting personnel, injectate/syringe, and other procedural materials. Examples include, but are not limited to:

  • o
    Patients should be advised to shower with chlorhexidine gluconate soap the night before and on the morning of the procedure.
  • o
    Spinal cord stimulator implant procedures should be performed in operating rooms with positive pressure and/or laminar flow with HEPA filters. Limiting in-and-out traffic from the operating room also decreases the risk of infection.
  • o
    Surgical hand scrub for physicians and scrub assistants
  • o
    If hair removal is necessary, an electric clipper should be used immediately prior to the procedure.
  • o
    Skin overlying the target region should be prepared for an aseptic procedure, preferably using chlorhexidine in alcohol.
  • o
    The patient's body should be draped entirely to create a sterile field, not only for the physician's hands but also for the leads and devices that will be brought into the field.
  • o
    Placing a sterile cover over the image collector
  • o
    A cap and face mask must be worn by all personnel in the operating room; sterile gloves and a sterile surgical gown must also be worn by the physician during the procedure.
  • o
    Double-gloving has been shown to reduce infection rates in the case of an inadvertent needle-stick injury. Glove changes before handling the pulse generator have been shown to reduce infection rates during procedures involving implanted pulse generators.
  • o
    Sterile single-use syringes and needles are required, and single-dose vials should be utilized when available.
  • o
    Acquisition, storage, and utilization of medications should adhere to relevant regulatory guidelines.
  • o
    An adherent, iodinated dressing may be placed over the sterile field, provided the patient does not have an iodine allergy.

3.7. Fluoroscopic imaging for SCS and DRGS placement

• •MRI sagittal and axial images should be reviewed to assess the geometry and size of the posterior epidural fat at the planned level of epidural access and along the intended path of lead placement to its target position.
• •Use of fluoroscopic guidance is necessary to establish segmentation and ensure appropriate lead placement.
• •The fluoroscopic technique should follow the ALARA (As Low As Reasonably Achievable) principles to minimize X-ray exposure for the patient and the healthcare team.
• •Obtain image(s) showing final SCS and DRGS lead placements in a lateral and AP view and, if indicated, a contralateral oblique view. Ensure appropriate landmarks are visible in the images (e.g., the last rib in the image in relation to the lead position for SCS).

3.8. Procedure

• •For cervical SCS lead placement, the entry level into the epidural space at or below C7/T1 is strongly advised, as at more cephalad levels, the dorsal epidural space and spinal canal diameter can be diminished.
• •Extensive irrigation of incisions and careful hemostasis before closure of the incisions and pockets is recommended.
• •Tunneling during the SCS/DRGS implantation should be done carefully in stages to avoid deep penetration into the abdominal or pleural cavity.
• •Avoid monopolar electrocautery near electrical equipment. Bipolar electrocautery or manual hemostasis should be utilized instead.

3.9. Post-procedure monitoring/follow-up

• •Patients should be monitored for an appropriate time following the procedure, depending upon the nature of the intervention and the agents utilized.
• •
  Provide detailed oral and written discharge instructions to patients that outline the following:

  • o
    restrictions and recommendations for the immediate post-procedure
  • o
    activity restrictions for six weeks following the permanent placement procedure (e.g., avoid bending, twisting, and heavy lifting)
  • o
    potential common side effects that may occur immediately post-procedure and in the days following the procedure [e.g., pain at the procedure/surgical site(s)]
  • o
    symptoms that merit immediate medical attention
  • o
    requirement to take analgesics only for moderate or severe pain during trial
  • o
    timing for resumption of usual medications and anticoagulants if discontinued for the procedure.
• •Ensure patients have a follow-up plan.

Sources

• Deer TR, Narouze S, Provenzano DA et al. The Neurostimulation Appropriateness Consensus Committee (NACC): recommendations on bleeding and coagulation management in neurostimulation devices. Neuromodulation. 2017; 20:51–62.

• Maus TP, Cohen I, McCormick ZL, Schneider BJ, Smith CC, Stojanovic MP, Waring PH (Eds). Technical Manual and Atlas of Interventional Pain and Spine Procedures. International Pain and Spine Intervention Society; 2024.

• Solomkin JS, Mazuski JE, Baron EJ et al. Guidelines for the selection of anti-infective agents for complicated intra-abdominal infections. Clin Infect Dis 2003; 37(15):997–1005.

4. Peripheral nerve stimulation (trial and permanent)

Ameet Nagpal, MD, MS, MEd, MBA; Yakov Vorobeychik, MD, PhD.

4.1. General

• •The physician must assess region-specific anatomical considerations that may influence the procedure's safety.

4.2. Personnel

• •Only physicians trained in peripheral nerve stimulation (PNS) should perform these procedures.

4.3. Contraindications

4.3.1. Absolute

• •Any active infection
• •Uncooperative patient or inability to obtain informed consent
• •Allergy to medication(s) that cannot safely be omitted or mitigated by pre-treatment
• •Hypertensive emergency/urgency
• •Anatomical derangements that compromise the safe and successful conduct of the procedure

4.3.2. Relative

• •Immunosuppression
• •Pregnancy - the risk of an elective procedure and the location of the stimulator hardware in relation to the fetus
• •Asymptomatic blood pressure >180/110
• •Uncorrected coagulopathy
• •Certain occupations and hobbies may increase the potential for interference with or hazard associated with PNS.
• •Severe psychiatric/psychological pathology
• •Inability to communicate the sensation of paresthesias in the distribution of the targeted nerve with stimulation testing
• •Need for future MRI depending on PNS technology and MRI compatibility
• •PNS may be safely performed in the presence of a pacemaker or automated implantable cardioverter defibrillator. In this scenario, collaboration with the cardiologist or electrophysiologist is advised.

4.4. Antithrombotics and bleeding disorders

• •The decision to continue or how to temporarily discontinue anticoagulation/antiplatelet (AC/AP) therapy must take into account potential complications in each scenario.
• •There is a quantifiable risk of life-threatening thrombotic events associated with discontinuation of therapeutic AC/AP agents.
• •The decision to temporarily discontinue AC/AP therapy and whether to employ a bridging strategy should include the patient and the physician prescribing the AC/AP therapy.
• •PNS has a variable bleeding risk depending on the location where the stimulator hardware is implanted.

4.5. Procedural sedation

• •In certain cases, moderate sedation or monitored anesthesia care (MAC) may be needed during trial lead placement for PNS. The use of sedation needs to be assessed and discussed on a case-by-case basis.
• •Depth of sedation needs to be discussed with the anesthesiologist, considering the ability to wake the patient to get reliable feedback during the procedure.
• •MAC may be used for permanent PNS implantation in selected cases.
• •Resuscitation drugs, appropriate monitoring equipment, and oxygen must be available if sedation is utilized.

4.6. Antibiotic prophylaxis

• •Optimization of hyperglycemia in diabetic patients decreases the risk of infection. While no specific hemoglobin A1C and/or point-of-care blood glucose levels are known to prevent infection, some data suggest that hemoglobin A1C levels above 8.0 % and FSBG levels above 200 increase the possibility of infection.
• •Cessation of nicotine products for 30 days has been shown to decrease the risk of infection.
• •Preoperative antibiotic administration: 1 dose within 30–120 min before incision/start of the procedure (cephalosporins such as cefazolin 1–3 g or cefuroxime 1.5 g intravenously. If allergic to beta-lactams, give clindamycin 600 mg. If the patient is colonized with MRSA, use vancomycin 1 g)
• •Second dose if the procedure goes beyond 4 h

4.7. Safe, aseptic practices

• •
  Strict aseptic technique should always be applied to the facility, patient, physician, assisting personnel, injectate/syringe, and other procedural materials. Examples include, but are not limited to:

  • o
    Patients should be advised to shower with chlorhexidine gluconate soap the night before and on the morning of the permanent PNS placement procedure.
  • o
    Peripheral nerve stimulator implant procedures should be performed in operating rooms with positive pressure and/or laminar flow with HEPA filters. Limiting in-and-out traffic from the operating room also decreases the risk of infection.
  • o
    Surgical hand scrub for physicians and scrub assistants.
  • o
    If hair removal is necessary, an electric clipper should be used immediately prior to the procedure.
  • o
    Skin overlying the target region should be prepared for an aseptic procedure, preferably using chlorhexidine in alcohol.
  • o
    The patient's body should be draped entirely to create a sterile field, not only for the physician's hands but also for the leads and devices that will be brought into the field.
  • o
    A cap and face mask must be worn by all personnel in the operating room, and sterile gloves and sterile surgical gown must be worn by the physician during the procedure.
  • o
    Double-gloving has been shown to reduce infection rates in the case of an inadvertent needle-stick injury. Glove changes before handling the pulse generator have been shown to reduce infection rates during procedures involving implanted pulse generators.
  • o
    Sterile single-use syringes and needles are required for any injections, and single-dose vials should be utilized when available.
  • o
    Acquisition, storage, and utilization of medications should adhere to relevant governmental guidelines.
  • o
    An adherent, iodinated dressing may be placed over the sterile field, provided the patient does not have an iodine allergy.

4.8. Procedure

• •Careful hemostasis before closure of the incisions and pockets is recommended.
• •Avoid monopolar electrocautery near electrical equipment where bipolar electrocautery can be utilized instead.

4.9. Post-procedure monitoring/follow-up

• •Patients should be monitored for an appropriate time following the procedure, depending upon the nature of the intervention and the agents utilized.
• •
  Provide detailed oral and written discharge instructions to patients that outline the following:

  • o
    restrictions and recommendations for the immediate post-procedure period

    • ●
      the location of the leads should dictate the duration of time for which activity should be restricted
  • o
    potential common side effects that may occur immediately post-procedure and in the days following the procedure
  • o
    symptoms that merit immediate medical attention
  • o
    requirement to take analgesics only for moderate or severe pain during trial
  • o
    timing for resumption of usual medications and anticoagulants if discontinued for the procedure
• •Ensure patients have a follow-up plan to monitor progress and for lead removal, as needed.

Sources

• Deer TR, Narouze S, Provenzano DA et al. The Neurostimulation Appropriateness Consensus Committee (NACC): recommendations on bleeding and coagulation management in neurostimulation devices. Neuromodulation. 2017; 20:51–62.

• Maus TP, Cohen I, McCormick ZL, Schneider BJ, Smith CC, Stojanovic MP, Waring PH (Eds). Technical Manual and Atlas of Interventional Pain and Spine Procedures. International Pain and Spine Intervention Society; 2024.

• Solomkin JS, Mazuski JE, Baron EJ et al. Guidelines for the selection of anti-infective agents for complicated intra-abdominal infections. Clin Infect Dis 2003; 37(15):997–1005.

Disclaimer

While these Safety Practices are intended to identify elements critical to the safe performance of interventional spine procedures, they are not intended to be inclusive of all proper methods relevant to the safe performance of spine procedures or exclusive of other methods of care reasonably utilized to obtain the same results. Nothing contained in these documents is intended to be used as a substitute for the care and knowledge of the individual clinician. They are guidelines based on evidence-informed expert consensus. IPSIS makes no representation and assumes no responsibility for the accuracy of the information contained or available through this website, and such information is subject to change without notice. Given the individual patient's clinical circumstances and preferences, the clinician's independent medical judgment should always determine patient care and treatment. Practitioners are advised to consider management options in the context of their training and background and institutional capabilities when selecting recommended treatment options. IPSIS is not responsible, nor does it assume any legal liability or responsibility for the accuracy, completeness, clinical efficacy, or value of any such information or apparatus, product, or process described or referenced through this website or the information contained therein.

Funding statement

No funding was utilized in the preparation of this manuscript.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.