Gupta 2006.
Methods | Triple‐blinded (participants, providers, outcome assessors) randomized placebo‐controlled trial Sequene generation by computer‐generated randomized numbers Follow‐up: 3 months |
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Participants | Participants: 60 men from a university hospital in Orebro, Sweden Operation: radical retropubic prostatectomy (for prostatic cancer) 2 groups, size: 28/28 (completed) Age (± SD), group 1, 2: 64.5 (± 4.9), 61.1 (± 4.3) All male participants Exclusion criteria: age > 70 Remarks: Gleason score, median (range), group 1, 2: 6 (5‐9), 6 (5‐9) |
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Interventions |
Group 1 (epidural group): on arrival to PACU, ropivacaine‐fentanyl‐adrenaline epidurally at 10 mL/h, IV PCA with 0.9% saline (bolus dose 1 mL, lockout 6 min, used NRS > 3). Group 2 (placebo group): on arrival to PACU, 0.9% saline via epidural at 10 mL/h, IV PCA with 1 mg/mL morphine (bolus dose 1 mg, lockout 6 min, used NRS > 3). In both groups, preoperative anxiolysis with 10 mg diazepam oral 1 h before scheduled surgery and 1 mg‐2 mg midazolam as needed during catheter placement. Standardized placement of epidural at T10 to 12 interspace, tested using 3 mL mepivacaine 2% with adrenaline then bolus dose of 3 mL to 4 mL mepivacaine 2% with adrenaline. Sensory blockade at T8 level. Standardized GA with propofol (participants 1‐55) or thiopentone (participants 56‐60), fentanyl, rocuronium, nitrous oxide in O2, sevoflurane. Intraoperative analgesia with 2% mepivacaine with 2 mL/h‐5 mL/h adrenaline by epidural infusion in all participants. Immediately before transfer to PACU epidural infusion was turned off. In PACU, nurse allowed to administer 1 mg‐2mg morphine bolus as needed if NRS > 5. 1 g paracetamol oral before surgery and every 6 h post‐op during hospitalization. Adjuvants: adrenaline Immediate post‐op pain control: significantly improved |
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Outcomes | Dichotomous: none Continuous: SF‐36 at 3 months Adverse effects: postoperative nausea, vomiting, sedation and bleeding were reported |
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Notes | We contacted study author for clarification on attrition, source of funding and conflict of interest but received no response. Funding sources: source of funding not reported. Conflicts of interest: conflict of interest statement not provided. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated randomized numbers", randomized "after successful insertion of the epidural catheter" |
Allocation concealment (selection bias) | Low risk | Quote: "every precaution was taken to achieve double blinding...hospital pharmacy sent two double‐blinded bags" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the patients and surgeons, anaesthesiologists and nurses involved in patient treatment were unaware of method of analgesia and every precaution was taken to achieve double blinding" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the SF‐36 was given before and 1 and 3 months after the operation to each patient". Participants, as well as providers, were blinded and the participants filled out the questionnaire themselves |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 60 participants were randomized, 4 participants were excluded after randomization with reasons and group assignments listed and balanced between groups. |
Selective reporting (reporting bias) | Low risk | Primary outcomes fully reported |
Null bias | Low risk | Quote: "median pain at rest at the incision site was low (< 4) and significantly lower in group E compared with group P at 4–24 h after the operation" |