Methods |
Randomised. |
Participants |
216 primigravidas in the first stage of labour. |
Interventions |
PCB was administered with 0.25% bupivacaine with epinephrine 1:400,000 or 1% carbocaine with epinephrine 1:400,000 10 mL on each side. |
Outcomes |
Duration of analgesia, serious side effects, fetal bradycardia. |
Notes |
3 infants died without any relationship to paracervical anaesthesia according to the authors. No details on causes of death were given. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not described. |
Allocation concealment (selection bias) |
Unclear risk |
Not described. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not blinded. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
90 cases were excluded in the data analysis of the duration of anaesthesia because the authors considered the recurrence of pain in these cases to be related to the head descent. |
Selective reporting (reporting bias) |
High risk |
See above. |
Other bias |
Low risk |
None identified. |