Zeidan 2004.
| Methods | Randomisation: random number table; "randomised in a double blinded manner". Blinding: not stated. |
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| Participants | Inclusions: 104 women, ASA 1 to 2, requesting epidural, singleton, nulliparous, 36 to 41 weeks' gestation, < 4 cm dilatation. Exclusions: multiple pregnancies, estimated fetal weight < 2500 gm, ED contraindicated, suspected fetal abnormalities, IV analgesics within the previous hour. No. lost to follow‐up: 3 in CSE group due to protocol violation; 1 in ED group withdrew. |
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| Interventions | Epidural (n = 51): 1000 mL Ringer's preload, left lateral; 10 to 20 mL 0.0625% (6.25 to 12.5 mg) bupivacaine plus fentanyl 15 to 30 µg. CSE (n = 50): preload as above: 1.25 mg bupivacaine plus fentanyl 25 µg. Subsequent management same in both groups: ED infusion commenced subsequently at patient request of bupivacaine 0.0625% plus fentanyl 1.5 µg/mL, initial 3 mL bolus followed by 6 to 10 mL/hr. |
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| Outcomes | Maternal: VAS pain score at 0, 5, 10, 15 and 30 minutes; additional analgesic interventions required, satisfaction, mobilisation, known dural tap, PDPH and blood patching; adverse events needing treatment ‐ hypotension, respiratory depression, nausea and vomiting, pruritus; major complications, mode of delivery. Fetal/neonatal: number admitted to the neonatal unit. |
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| Notes | Saudi Arabia. Table 4 not in published paper. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stated, "using random number table". |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Stated, "double blinded", no other information. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 women from CSE group were excluded because of protocol deviation, 1 patient from the epidural group chose to discontinue her participation. No loss to follow‐up. |
| Selective reporting (reporting bias) | Low risk | The primary and secondary outcomes were reported. |
| Other bias | Low risk | No other bias evident. |
ASA: American Society of Anesthesiologists BFSE: mixture of bupivacaine, fentanyl, sodium bicarbonate and epinephrine BMI: body mass index bpm: beats per minute cm: centimetre CSE: combined spinal‐epidural CSF: cerebrospinal fluid CTG: cardiotography ED: epidural hr: hour IJOA: International Journal of Anesthesiology IT: intrathecal IV: intravenous LA: local anaesthetic LSCS: lower segment caesarean section µg: microgram mg: milligram min: minute mL: millilitre NaHCO3: sodium bicarbonate no.: number PCEA: patient‐controlled epidural analgesia PDPH: post dural puncture headache SBP: systolic blood pressure SpO2: saturation of oxygen VAS: visual analogue score