Lam 2015.
| Methods | Placebo‐controlled, randomized clinical trial Sequence generation by computer‐generated random numbers Follow‐up for 6 months |
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| Participants | Participants: 36 adults in a university setting in Alberta, Canada Operation: unilateral total breast mastectomy +/‐ axillary lymph node dissection 2 groups, size: 18/18 Age (± SD), group 1, 2, 4: 63.9 years (16.7), 60.2 (13.1) All women Exclusion criteria: not specified |
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| Interventions |
Group 1 (PVB): participants received an ultrasound‐guided PVB (regional anaesthetic not specified) or combined with a multimodal regimen consisting of propofol‐based total intravenous anaesthesia with ketorolac, gabapentin, ranitidine, paracetamol, and ondansetron. Group 2 (control): same intervention as above except sham block was substituted for local anaesthesia. Adjuvants: none Immediate post‐op pain control: no improvement |
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| Outcomes | Dichotomous: pain vs no pain Continuous: none Other reported: propofol and fentanyl consumption, postoperative morphine equivalent consumption, frequency of postoperative nausea and vomiting |
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| Notes | We were unable to obtain additional information about randomization and blinding methods from the study author. Funding sources: funding for the study not reported Conflicts of interest: there was no statement on conflict of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "following patient allocation with a computer‐generated sequence..." |
| Allocation concealment (selection bias) | Low risk | Quote: "consenting patients were randomized to either the treatment group or the control group via sealed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Sham block was used and participants were well blinded. No comment on personnel blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not described |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Degree of attrition not described |
| Selective reporting (reporting bias) | Low risk | No subgroup analysis noted |
| Null bias | High risk | Quote: "pain scores were similar at all time points within the first 24 hours" |