Vrooman 2015.
| Methods | Triple‐blinded (participant, provider, outcome assessor), placebo‐controlled, randomized clinical trial Sequence generation by computer‐generated random numbers Follow‐up for 3 and 6 months |
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| Participants | Participants: 78 adults in a university setting in USA Operation: robotic cardiac surgery 2 groups, size: 39/39 Age (± SD), group 1, 2: 56 (11), 58 (10) Men/women, group 1, 2: 31/8, 29/10 Exclusion criteria: history of severe psychiatric issues (e.g. depression, somatoform conversion disorder, and borderline personality disorder); addiction to alcohol, opioids, or illegal substances; known history of sensitivity to amide LAs; severe hepatic disease; or pregnant |
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| Interventions |
Group 1 (lidocaine): anaesthetic technique not described. The 5% lidocaine transdermal patches contained 700 mg of lidocaine. Each self‐adhesive patch was 10 cm x 14 cm. Up to 3 patches were applied to maximize analgesia while reducing the risk of systemic toxicity. Patches were applied for 12 h, removed for the subsequent 12 h, and then new patches were applied. This process was continued for 6 months or until participants no longer required analgesia. Additional postoperative analgesia was provided by participant‐controlled fentanyl (20 mg bolus, 6‐min lockout, no hourly limit). Morphine or hydromorphone was substituted in participants reporting sensitivity to fentanyl. PCA was continued for up to 3 days, with the exception of a single participant who was treated for 5 days, until participants could tolerate oral opioid medications such as oxycodone 5 mg to 10 mg every 4‐6 hours as needed. Participants who required more than 40 mg of oxycodone, or equivalent, per day were supplemented with fentanyl 25 mg/h transdermal patches Group 2 (control): same intervention as above except sham patches were used. Adjuvants: none Immediate post‐op pain control: no improvement |
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| Outcomes | Dichotomous: none Continuous: VAS/VRS Secondary: VAS at POD 3; VRS at 1 week and 1 month, the Depression Anxiety Stress Score recorded the day before surgery, GPE‐a measure of participant satisfaction, recorded after 1 week, 1 month, 3 months, and 6 months. PDI at 3 and 6 months |
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| Notes | Funding sources: funding for the study was provided by Endo Pharmaceuticals. Conflicts of interest: "none of the authors has a personal financial interest in this research." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed by our Research Pharmacy and was based on computer‐generated codes" |
| Allocation concealment (selection bias) | Unclear risk | Allocation of concealment was not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all investigators and clinicians were fully blinded to treatment." |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "incisional pain was evaluated over 6 months with data collected by an independent study coordinator who was blinded to treatment." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no attrition and ITT analysis was performed |
| Selective reporting (reporting bias) | Low risk | No subgroup analysis was performed |
| Null bias | High risk | Quote: "lidocaine 5% patches did not influence any measure of acute or persistent incisional pain" |