Methods | Double‐blinded (participant/outcome assessor), randomized clinical trial Sequence generation by a computer‐based, random numbers generator Follow‐up: 3 months |
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Participants | Participants: 60 women at a university hospital in Ontario, Canada Operation: caesarean section Groups, size: 20/20/20 Age (± SD), group 1, 2, 3: 33 (± 3), 32 (± 7), 33 (± 4) All female participants Comorbidities: previous caesarean delivery, groups 1, 2, 3 (16, 14, 15) Remarks: ASA I, II, and III |
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Interventions | All participants received SA with 0.75% bupivacaine 10 mg‐12 mg, fentanyl 10 µg and morphine 150 µg Group 1 (high‐ropivacaine): post‐op: a 22‐G, 50 mm or 80mm Pajunk Uniplex nanoline needle was introduced into the fascia between the internal oblique and transversus abdominis muscles. After confirmation of needle placement, the study solution was injected in 5 mL increments after negative aspiration. Study solution for high‐ropivacaine group consisted of 0.5% ropivacaine 3 mg/kg (up to a maximum of 300 mg) plus saline to total 60 mL of fluid. TAP blocks were performed bilaterally. Group 2 (low‐ropivacaine): post‐op: same method as group 1, but study solution consisted of 0.25% ropivacaine 1.5 mg/kg (up to a maximum of 150 mg) plus saline to total 60 mL.TAP blocks were performed bilaterally. Group 3 (placebo): post‐op: TAP blocks consisting of 60 mL of saline were administered bilaterally using same method as groups 1 and 2. Adjuvants: none Immediate post‐op pain control: no difference |
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Outcomes | Dichotomus: none Continuous: NRS at 3 months Other reported: the time to first request for additional analgesia, the total consumption of opioids, antiemetics and anti‐pruritics 72 h postoperatively Adverse events: none reported |
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Notes | Funding sources: "this study was supported in part by a grant from the Lawson Health Research Institute." Conflicts of interest: "the authors have no conflicts of interest to declare." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were randomly assigned using a computer generated table of random numbers to one of three groups." |
Allocation concealment (selection bias) | Low risk | Quote: "group allocations were concealed in sealed opaque envelopes that were opened only after patient consent was obtained.." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the patients, anesthesiologists, and nursing staff involved in direct patient care were unaware of the study group allocations." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "patients were interviewed at regular intervals by an investigator unaware of group allocation..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Of the 60 participants enrolled, 59 completed the study. |
Selective reporting (reporting bias) | Low risk | No subgroup analysis or selective reporting was noted. |
Null bias | High risk | Quote: "neither high‐ or low‐dose TAP blocks as part of a multimodal analgesia regimen including intrathecal morphine improved pain scores." |