Haidl 2020.
Study characteristics | ||
Methods | Prospective randomised controlled study | |
Participants | Setting: recruited from Akershus University Hospital, Norway Sample size: N = 151 Participants: age 29.8 ± 4.3 years (BI) and 30.4 ± 4.1 years (AMB) Inclusion criteria: Adult women, ASA<3, singleton term pregnancy (gestation >37 weeks), maximum of one previous delivery. Exclusion/ criteria: Poor communication skills in Norwegian or English, height <150cm, pre‐eclampsia, contraindication to epidural. 1 women in BI group excluded after randomisation ‐ withdrew consent. |
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Interventions | AMB (n = 75): 0.1% bupivacaine + fentanyl 2 µg/mL at 5 mL every 60 minutes following a 10 mL loading dose. First bolus administered 15 minutes after loading dose. PCEA (5 mL, lockout 20 minutes) allowed, breakthrough pain despite PCEA managed with a physician‐administered epidural bolus. BI (n = 75): 0.1% bupivacaine + fentanyl 2 µg/mL at 5 mL/h infusion following a 10 mL loading dose. Infusion started 15 minutes after loading dose. PCEA (5 mL, lockout 20 minutes) allowed, breakthrough pain despite PCEA managed with a physician‐administered epidural bolus. |
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Outcomes | LA consumption Number of participants needing physician intervention Duration of treatment Mode of delivery Overall satisfaction Motor block |
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Notes | Study dates: March 2017 to September 2018 Funding sources not declared No conflict of interests declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by computer generated algorithm: Quote:"The group assignment was determined by a computer generated algorithm" |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment via sealed envelopes, but it was not stated if envelopes were opaque: Quote:"...and kept in individual sealed envelopes until patients were included." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded, but the anaesthetist was not blinded: Quote:"All participants and study personnel assessing patients were blinded to the intervention. The anesthetist including the patient, and starting the treatment, was not blinded to the intervention." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded: Quote:"All participants and study personnel assessing patients were blinded to the intervention." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition: only 1 patient was excluded after randomisation |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | Appears to be free of other sources of bias. |