Ibarra 2011.
Methods | Blinded (PACU nurses, outcome assessor), controlled, randomized clinical trial Computer‐generated randomization in blocks of 2 using sealed, opaque envelopes Follow‐up: 5 months |
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Participants | Participants: 40 adults in a university hospital setting in Albacete, Spain Operation: radical mastectomy and conservative breast surgery for breast cancer 2 groups, size: 20/20 Age: not reported Men/women: 0/40 |
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Interventions |
Group 1 (preoperative PVB): single shot PVB at T4 with ropivacaine (0.5% without epinephrine, 25 mL to 30 mL, doses maximum 150 mg; using nerve stimulations according to Naja but only one single injection), GA (LMA using sevoflurane and remifentanil 0.05 to 0.1 mcg/kg/min only in the first 20‐30 min), post‐op: intravenous morphine (0.1 mg/kg), dexketoprofen 50 mg IV plus 25 mg every 8 h as needed for pain and paracetamol (1 g every 6 h) Group 2 (no block): no block, GA (LMA using sevoflurane and remifentanil 0.05 mcg/kg/min to 0. 02 mcg/kg/min), post‐op: IV morphine (0.1 mg/kg), dexketoprofen 50 mg IV plus 25 mg every 8 h as needed for pain and paracetamol (1 g every 6 h) Adjuvants: none Immediate post‐op pain control: not significantly improved |
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Outcomes | Dichotomous: number of participants with pain (including detailed number per group on myofascial pain, breast phantom pain or neuropathic pain) at 3 and 5 months per group Continuous: not reported Effective regional anaesthesia: one participant had an unsuccessful block but was NOT excluded, yet PVBs did not reduced the severity of postoperative pain. |
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Notes | We acknowledge the study author's response regarding randomization, allocation concealment and blinding, dosing and attrition Funding sources: source of funding not stated Conflicts of interest: conflict of interest not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “computer generated list”, “randomization in blocks of two”. Low risk of bias |
Allocation concealment (selection bias) | Low risk | Quote: “patients were assigned as they arrived in the preoperative clinic”, “The anaesthesiologist [enrolling the participant] did not know in which group the patient was going to be enrolled”. “The anaesthesiologist [in the OR] did not know the group allocation, until the patient reached the operating room.” “The randomization number was included in the chart in a sealed opaque envelope.” Low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “the recovery room nurses did not know the anaesthetic technique used in each case.” “The surgeon knew” if a block was performed. Participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “the outcome observer conducting the interview did not know the group allocation.” |
Incomplete outcome data (attrition bias) All outcomes | High risk | The numbers excluded in each group for radiotherapy and lost to follow‐up, respectively are unclear. Significant attrition with unclear group allocation may have caused bias, but no ITT analysis considered. |
Selective reporting (reporting bias) | Low risk | Expected primary outcomes fully reported on |
Null bias | High risk | Quote: "no significant differences in acute pain were observed" |