Gomez 2001.
Methods | Randomisation: method not stated. Blinding: stated as "single blinded" study but unclear as to specifically whether the outcome assessor was blinded to allocation. Criteria for rescue analgesia: when VAS pain score 3 or greater, 4 mL bolus bupivacaine 0.25% administered. Minimum 30 min between injections. Nil lost to follow‐up. |
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Participants | Inclusions: 42 ASA 1 or 2 women in spontaneous labour with a singleton, vertex presentation fetus. Cervical dilatation 2 to 5 cm. Exclusions: obstetric pathology, meconium stained liquor, ruptured membranes, previous caesarean section. No. lost to follow‐up = 0. |
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Interventions | Epidural (n = 21): test dose 3 mL bupivacaine 0.25% + adrenaline 1:200,000 followed by 5 mL of the same solution. Immediate infusion of bupivacaine 0.125% with fentanyl 1 µg/mL at 8 mL/hr. CSE (n = 21): sitting, otherwise technique not stated. IT injection of bupivacaine 2.5 mg + 25 µg fentanyl + adrenaline 1:200,000. Once VAS of 3 to 4, 8 mL bupivacaine 0.125% + adrenaline 1:200,000 and an infusion of the same solution and rate as the epidural group. |
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Outcomes | Maternal: VAS pain scores at 5, 10, 15 and 30 min and then hourly. At the same time intervals sensory block to pinprick and motor block (Bromage scale) were assessed. Number of additional rescue analgesia boluses was noted. VAS maternal satisfaction recorded at delivery. Presence of arterial hypotension (decrease from baseline of greater than 20%) was documented. Maternal bradycardia (rate less than 60 bpm) was noted. Adverse effects noted: nausea and vomiting, pruritus. Mode of delivery recorded as normal, instrumental or caesarean. Neonatal: occurrence of fetal bradycardia less than 100 bpm noted. No recorded neonatal assessments. |
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Notes | Spanish (translated). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The patients were divided randomly into two groups". |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated, except "prospective, randomised, blinded study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes are stated. |
Other bias | Low risk | No other bias evident. |