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. 2018 Jun 21;2018(6):CD007105. doi: 10.1002/14651858.CD007105.pub4

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
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
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
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.
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
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"