Characteristics of ongoing studies [ordered by study ID]

ISRCTN46621916
Trial name or title	Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study
Methods	Single-blinded (outcome observer) clinical RCT Sequence generation via computer-generated randomization list follow-up: 6 months
Participants	Participants: all women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust, aged ≥ 18 years Operation: mastectomy with or without axillary involvement 2 groups, size: N/A Age (range), groups 1, 2: N/A All female participants Exclusion criteria: inability to give informed consent; primary reconstructive surgery; hypotension, hypovolaemia or any form of shock; known allergy or sensitivity to LA agents, morphine, paracetamol or ondansetron; pregnancy; daily opioid analgesic use; inability to understand or use a PCA device; inability to understand or complete the visual analogue assessment tools; concurrent participation in another interventional study that might conflict with this study
Interventions	Group 1 (saline, control arm): 0.9% sodium chloride, is sourced from standard NHS supplies at the participating sites, delivered by means of an infusion catheter and device, supplied as a sterile prepacked kit and licensed for the delivery of LA. At the end of the surgical procedure the surgeon inserts the infusion catheter percutaneously into the subpectoral plane under direct vision within the surgical field. After skin closure, a 20 mL bolus of comparator treatment is given via the catheter, which is then connected to the infusion device to provide an infusion of study treatment at a continuous rate of 5 mL/h for 24 h Group 2 (levobupivacaine): 0.25%levobupivacaine (chirocaine), an established LA infusion agent, prepared as a 2.5 mg/mL solution and packaged by the manufacturer (Abbott) delivered by means of an infusion catheter and device, supplied as a sterile prepacked kit and licensed for the delivery of LA. At the end of the surgical procedure the surgeon inserts the infusion catheter percutaneously into the subpectoral plane under direct vision within the surgical field. After skin closure, a 20 mL bolus of active or comparator treatment is given via the catheter, which is then connected to the infusion device to provide an infusion of study treatment at a continuous rate of 5 mL/h for 24 h. In the active treatment arm this equates to a 50 mg bolus of levobupivacaine followed by an infusion of 12.5 mg/h Both groups: paracetamol 1 g IV, ondansetron 4 mg IV, and dexamethasone 3.3 mg (+/− 0.1 mg) IV unless clinically contraindicated. Intubation and ventilation at anaesthetist’s discretion – with muscle relaxant of anaesthetist’s choice. Sevoflurane in air: depth of anaesthesia at anaesthetist’s discretion. Fentanyl: 3 μg/kg to 6 μg/kg IV during surgery. Fluids: at anaesthetist’s discretion. All other nonopiate and nonantiemetic drugs: at anaesthetist’s discretion. IVrescuemorphine in recovery unit, 2 mg increments IVmorphine PCA, 1 mg bolus, 5 min lockout. Paracetamol 1 g 6-hourly orally. Ibuprofen 400 mg 8-hourly orally unless contraindicated as needed: ondansetron 4 mg (IV) 8-hourly and cyclizine 50 mg (IV) 8-hourly Adjuvants: none Immediate postop pain control: data not available
Outcomes	Dichotomous: none Continuous: VAS pain scores at rest at 24 h, 14 days and 6 months after surgery; BPI at 6 months Secondary: total morphine consumption (mg) in the first 24 h (defined as the 24 h following start of the subpectoral infusion), including all morphine given in the recovery unit and cumulative PCA use as recorded by the PCA device and (2) total pain over the first 24 h, as defined by measurement of the area-under-the-curve of each participant’s self-reported pain scores at rest, measured using a VAS. VAS pain scores are recorded in the recovery unit and then at 4-hourly intervals for the first 24 h. Secondary outcome measures include the number of PCA attempts in the first 24 h following start of infusion. Incidence of postoperative nausea and/ or vomiting and use of supplemental analgesics and postoperative antiemetics in the first 24 h; self-reported analgesia use at 14 days and 6 months; duration of hospital stay; shoulder movement assessed by goniometry at 24 h, 14 days and 6 months following surgery; shoulder function (as measured by the validated 31) at 6 months. Following the participant’s discharge, the length of stay in hospital is recorded by the research nurse Adverse events reported: data not available
Starting date	15 October 2012
Contact information	Dr Roger Langford, roger.langford@rcht.cornwall.nhs.uk
Notes
Liew 2011
Trial name or title	Postoperative pain relief after laparoscopic gynaecological surgery: a pilot study of pre-emptive superior hypogastric plexus block versus placebo using ropivacaine. The LAP-HYPOPLEX study
Methods	Quote: a “prospective double-blind randomised controlled trial” with parallel assignment; this is an efficacy study, single centre
Participants	Women undergoing (quote:) “gynaecological diseases for complex laparoscopic surgery”
Interventions	The superior hypogastric plexus is identified with the laparoscope during surgery, the women receive pre-emptive infiltration of 20 mL of 0.75% ropivacaine or placebo
Outcomes	Participants are contacted 6 months after surgery with a postal questionnaire and telephone interview to assess chronic pain syndrome
Starting date	Unclear, before 2012
Contact information	Liew A: Anaesthetics, Sydney Women’s Endosurgery Centre, St George Private Hospital, Sydney, NSW, Australia
Notes	www.aaic.net.au/document/?D=20110649
Michael 2014
Trial name or title	Continuous transgluteal sciatic nerve block to prevent phantom limb pain after trans-femoral amputation
Methods	Prospective, randomized double-blind trial Single centre
Participants	Ages eligible for study: not specified Genders eligible for study: both Estimated enrolment: 40 People undergoing trans-femoral lower limb amputation
Interventions	Quote. “a pre-operative transgluteal sciatic perineural catheter is placed for 5-days continuous infusion of L-Bupivacaine vs saline.”
Outcomes	Quote: “pain assessment via Mc Gill score and OBAS (Overall Benefits of Analgesia Score) test on at 3, 6, and 12 months.”
Starting date	December 2013
Contact information	Michael Michael, MD e-mail: medici.anestesia@ospedale.varese.it
Notes	We were unable to contact the study author to request more information
NCT00418457
Trial name or title	Regional anaesthesia and breast cancer recurrence: prospective, randomized, double-blinded, multicenter clinical trial to compare postoperative analgesia and cancer outcome after combined paravertebral versus thoracic epidural versus general anaesthesia for breast cancer surgery
Methods	Prevention, randomized, open-label, active-control, parallel-assignment, efficacy study
Participants	Ages eligible for study: 18–85 years Genders eligible for study: women only Estimated enrolment: 1600 Women undergoing mastectomies or isolated lumpectomy with axillary node dissection
Interventions	Combined paravertebral vs thoracic epidural vs general anaesthesia
Outcomes	Primary outcome is cancer recurrence with a follow-up of 5 years. Secondary outcomes include chronic pain, among others, with a follow-up of 6 and 12 months
Starting date	January 2007
Contact information	Nancy Graham, RN Tel: +1216-445-7530 e-mail: grahamn@ccf.org
Notes
NCT01626755
Trial name or title	Prevention of phantom limb pain after transtibial amputation (PLATA)
Methods	Randomized, double-blind (participant, caregiver, outcomes assessor), parallel-assignment, efficacy study, multi-centred
Participants	Ages eligible for study: ≥ 18 years Genders eligible: both Estimated enrolment: 400
Interventions	Quote. “all patients will receive standard optimised intravenous anaesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). People in the intervention group will receive additional infusion of local anaesthetic via a sciatic nerve catheter placed under ultrasound guidance.”
Outcomes	Point prevalence of chronic phantom limb pain (time frame: 12 months after amputation)
Starting date	August 2013
Contact information	Philipp Lirk, MD Tel: +31(20)566 ext 4032 Email: p.lirk@amc.uva.nl
Notes	ClinicalTrials.gov Identifier: NCT01626755
NCT02002663
Trial name or title	Continuous wound infusion of local anaesthetic and steroid after major abdominal surgery: study protocol for a randomized controlled trial
Methods	Double-blinded (participant and outcome assessor) clinical RCT Sequence via computer-generated list follow-up: 3 months
Participants	Participants: 120 men and women at university hospital in Italy Operation: major abdominal surgery by laparotomy 2 groups, size: 60/60 Age: 18–85 years old Men/women: not reported Exclusion criteria: regular use of opioid analgesics, history of drugs or alcohol abuse (or both), postoperative hospitalisation in intensive care with sedation or mechanical ventilation (or both), neurological disorders, any heart conduction disease, any cognitive or mental disorder hindering a participant from providing informed consent, BMI > 30, diabetes (type I or II), allergy to study drugs, and use of epidural analgesia
Interventions	Group 1 (ropivacaine infusion): GA is given using propofol and midazolam (as deemed appropriate by the anaesthesiologist), opioids (fentanyl 0.2 μg/kg or remifentanil 0.1–0.25 mg/kg/min or both), and muscle relaxants (cisatracurium/rocuronium) and maintained with sevoflurane. A morphine bolus of 0.15 mg/kg is given 30–45 min before the end of surgery. An infusion catheter is placed by the surgeon in the fascial plane between peritoneum and fascia transversalis, and a 10 mL bolus of 0.2% ropivacaine is administered immediately after muscular plane closure; the catheter is then connected to an electronic pump to give a continuous infusion of pain medications. During the first 24 h, all participants receive ropivacaine 0.2% + methylprednisolone 1 mg/kg, 10 mL/h (total volume of 240 mL in 24 h) continuous wound infusion; additionally, either paracetamol (acetaminophen) 1000 mg or ketorolac 30 mg every 8 h is prescribed. Rescue analgesia in the first 48 h is provided by PCA pump with morphine (0.5 mg/mL, bolus 1 mg, lock-out 5 min, 20 mg limit every 4 h) Group 2 (control): exactly the same as above, except after 24 h, 10 mL/h continuous infusion of saline 0. 9% given to control group Adjuvants: methylprednisolone Immediate post-op pain control: not reported
Outcomes	Dichotomous: none Continuous: NRS Other reported: acute postoperative pain, use of morphine equivalents, analgesic consumption, side effects (postoperative nausea and vomiting, sedation, and any signs of LA or steroid systemic toxicity), and differences in terms of wound healing or wound infections
Starting date	October 2013
Contact information	Dario Bugada, M.D. Email: dariobugada@gmail.com
Notes	ClinicalTrials.gov Identifier: NCT02002663
Theodoraki 2016
Trial name or title	The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair
Methods	Double-blinded (participant, outcome assessor), placebo-controlled, randomized clinical trial Sequence generation not described Follow-up for 6 months
Participants	Participants: 35 adults in a university setting in Athens, Greece Operation: inguinal hernia repair 2 groups, size: not specified Age (± SD), group 1, 2: not specified Men/women, group 1, 2: not specified Exclusion criteria: inability to consent to the study; BMI > 40 kg/m2; skin infection at the puncture site; contraindication to monoamide LAs, paracetamol, NSAID’s (parecoxib); preoperative use of opioids or NSAIDs for chronic pain conditions
Interventions	Group 1 (ropivacaine): during the operation participants all received remifentanil infusion titrated as to maintain heart rate and systolic arterial pressure within 20% of baseline. In the PACU, participants received morphine boluses, until the NRS score was ≤ 3. They also had access to PCA device administering 1 mg doses of morphine as rescue analgesia. TAP block was applied intraoperatively using 20 mL of 0.75% ropivacaine Group 2 (control): same intervention as above except saline was substituted for ropivacaine for TAP block Adjuvants: none Immediate post-op pain control: meaningful improvement
Outcomes	Dichotomous: none Continuous: NRS Secondary: intraoperative dose of remifentanil, mg of IV morphine used in the PACU, and total dose of morphine administered via the PCA device
Starting date	January 2014
Contact information	Anne Theodoraki, M.D. Email: ktheodoraki@hotmail.com
Notes	ClinicalTrials.gov Identifier: NCT02030223

BMI: body mass index; BPI: Brief Pain Inventory; g: gram; GA: general anaesthesia; h: hours; IV: intravenous; mg: milligram; LA: local anaesthetic; N/A: not applicable; NHS: National Health Service; NRS: numerical rating scale; OBAS: overall benefits of analgesia score; PACU: postanaesthesia care unit; PCA: patient controlled analgesia; TAP: transversus abdominis plane; TEA: thoracic epidural anaesthesia; VAS: visual analogue scale; μg: microgram