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. 2018 Apr 25;2018(4):CD007105. doi: 10.1002/14651858.CD007105.pub3
Methods Double‐blinded (participant/outcome assessor), randomized clinical trial
Sequence generation by a computer‐based, random numbers generator
Follow‐up: 3 months
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
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
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
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."
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."