Dunn 1998.
| Methods | Randomisation: method not stated. "Patients were randomised into 2 groups." Blinding: outcome assessor blinded. Criteria for rescue analgesia: if inadequate analgesia after 20 min, 15 mL bupivacaine 0.125% given down epidural, followed by 10 mL lidocaine 2% if needed. If this was ineffective then catheter replaced and data excluded from analysis. Statistical analysis not performed on an intention‐to‐treat basis. |
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| Participants | Inclusions: 70 healthy ASA 1 or 2 women in early labour (cervical dilatation < 5 cm). Exclusions: history of previous caesarean section or IV opioids before requesting epidural analgesia. No. lost to follow‐up: 1. |
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| Interventions | Epidural (n = 35): test dose 3 mL lidocaine 1.5% + 1:200,000 epinephrine. Then bolus sufentanil 40 µg in 10 mL saline down epidural catheter. Study ended at request for additional analgesia. CSE (n = 34): single space, needle‐through‐needle, sitting. IT injection sufentanil 10 µg diluted to 1 mL. Epidural catheter sited but nothing administered down it until requested, at which point study ended. |
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| Outcomes | VAS pain scores and severity of side effects assessed at 5, 10, 15, 20 and 30 min, and thereafter every 30 min. Maternal blood pressure, pulse and respiratory rate, and motor block were assessed at the same times. Time of request for additional analgesia noted and study ended. Mode of delivery noted and incidence of PDPH recorded. Neonate assessed by Apgar scores. | |
| Notes | USA. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Stated, "randomised into 2 groups". |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Stated, "observations were made by an individual blinded to the analgesic technique". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One patient lost to follow‐up. |
| Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes reported. |
| Other bias | Low risk | No other bias evident. |