Ledan 1993.
Methods | Treatment allocation:
Women randomly assigned to receive spinal or epidural anaesthesia by drawing lots. Allocation concealment: No details given. Documentation of exclusions: No exclusions. Blinding of outcome assessment: No blinding of intraoperative outcomes ‐ the anaesthetist evaluated anaesthetic quality and gave appropriate treatment. Losses to follow up: None. |
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Participants | Inclusion criteria:
20 women (ASA 1) after normal full‐term pregnancy wanting a regional anaesthetic. Exclusion criteria: Contra‐indications to regional anaesthesia. Number lost to follow up: None. |
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Interventions | Spinal anaesthesia:
24 gauge Sprotte needle inserted at L2‐3. 0.08 mg/cm of 0.5% hyperbaric bupivacaine injected in 30 seconds. Women placed in left lateral 15 degree tilt after induction of anaesthesia. Epidural anaesthesia: 17 G Tuohy needle inserted in sitting position at L2‐3. 10 ml 0.5% plain bupivacaine injected followed 5 minutes later by 20 ml/hour infusion until T6 level achieved. Women placed in left lateral 15 degree tilt after induction of anaesthesia. All women received 1000 ml of Ringer‐lactate solution and 30 mg subcutaneous ephedrine before having regional anaesthesia. Hypotension (systolic blood pressure < 100 mmHg or a fall of 30% from pre‐anaesthetic level) was treated with 10 mg ephedrine and infusion of Ringer‐lactate solution. The anaesthetist evaluated anaesthetic quality and gave a 50/50 mixture of oxygen and nitrous oxide when anaesthetic quality was deemed insufficient. Perioperative complications were noted ‐ nausea, vomiting and bradycardia but no interventions were described. |
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Outcomes | Number of women receiving additional interventions for pain relief during surgery was recorded. A 50/50 mixture of oxygen/nitrous oxide was given if anaesthetic quality was deemed insufficient by the anaesthetist. Number of women needing treatment for hypotension was recorded. Onset time for analgesia to reach T6 was recorded. Postoperatively, the number of women receiving paracetamol for analgesia was recorded. Number of women who were satisfied with the anaesthetic technique was also recorded. Neonates were assessed but no interventions were mentioned. |
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Notes | France. Study translated from French to English. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |