Palomaki 2005a.
Methods | Randomised. | |
Participants | 397 women with normal pregnancy and normal latent phase of labour age 18‐40 years, singleton, cephalic presentation, at 37‐42 weeks' gestation, normal cardiotocogram before PCB, ruptured membranes, cervical dilatation 3‐7 cm, no fetopelvic disproportion, no chronic maternal illnesses. | |
Interventions | PCB was administered with Kobac needle at the 3, 4, 8, 9 o'clock positions in the lateral fornix of the vagina at the depth of 3‐4 mm. | |
Outcomes | The intrauterine pressure, Apgar score, cord artery acid‐base balance, clinical outcome, analgesic effect of the block measured with visual analogue scale, median time from PCB to delivery, the type of delivery (spontaneous, vacuum extraction, caesarean section), admission to neonatal intensive care unit (NICU). | |
Notes | Non‐randomised pilot study to characterise the use of levobupivacaine in PCB, which included 40 women, was initially undertaken. Racemic bupivacaine was compared to levobupivacaine. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete data. |
Selective reporting (reporting bias) | Low risk | None identified. |
Other bias | Low risk | No other bias were identified. |