Smaldone 2010.
| Methods | Double‐blinded (participant/outcome assessor), randomized clinical trial Sequence generation not specified Follow‐up: 3, 6 months |
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| Participants | Participants: 60 men in a hospital setting in Philadelphia, PA Operation: open radical retropubic prostatectomy Groups, size: 29/31 Age: not specified All male participants |
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| Interventions |
Group 1 (multimodal analgesia): pre‐op: PVB with 5 mL of 0.5% ropivacaine per level (T10‐T12) and oral celecoxib (400 mg preoperatively and 200 mg twice daily for 7 days postoperatively). Intra‐op: IV ketamine (10 mg) following induction. Post‐op: all participants had access to morphine (PCA) Group 2 (PCA): pre‐op: participants received placebo equivalents as treatment group ‐ sham tablets and sham saline injections. Post‐op: all participants had access to morphine (PCA) Adjuvants: none Immediate post‐op pain control: significantly improved, significantly reduced analgesic consumption |
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| Outcomes | Continuous: SF‐36 at 3, 6 months Dichotomus: none Other reported: VAS at 24 hours, morphine consumption postoperatively Adverse events: none reported |
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| Notes | We were unable to obtain additional information regarding pain outcomes or about randomization and blinding methods from the study author. Funding sources: none received Conflicts of interest: conflict of interest not discussed |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation not specified |
| Allocation concealment (selection bias) | Unclear risk | Concealment of allocation not specified |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "all patients, staff and physicians were blinded to treatment group assignment." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors not discussed |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Amount of follow‐up and attrition not specified |
| Selective reporting (reporting bias) | Low risk | No subgroup analysis or selective reporting was noted |
| Null bias | High risk | Quote: "there were no significant differences detected in SF‐36 scores at 2, 12, and 24 weeks." |