Vegfors 1992.
Methods | Treatment allocation:
Women randomly assigned to receive spinal or epidural anaesthesia. No other details of methodology given. Allocation concealment: No details given. Documentation of exclusions: Three women in epidural group excluded because "they did not fulfil the inclusion criteria". No other details given. Included in intention‐to‐treat analysis. Blinding of outcome assessment: Not mentioned. Losses to follow up: Three women. |
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Participants | Inclusion criteria:
100 women requesting regional anaesthesia for elective caesarean section at a university hospital in Sweden. Inclusion criteria were normal pregnancy at term and no known maternal disease. Exclusion criteria: Three women in epidural group excluded because "they did not fulfil the inclusion criteria". No other details given. Number lost to follow up: Three (see above). |
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Interventions | Spinal anaesthesia:
2.5 ml of bupivacaine 5 mg/ml in 8% glucose, performed in the sitting position with a 25 gauge Quincke needle. Women placed supine with left lateral tilt within 1 minute of injection. Height of block tested with temperature discrimination 10 minutes after injection. Epidural anaesthesia: Epidural catheter inserted with women in the lateral position through a 17 gauge needle. Mepivacaine 20 mg/ml with adrenaline 5 mg/ml injected via catheter, test dose of 5 ml first, followed 5 minutes later by main dose of 17 ml as a bolus injection. 5 ml supplements given if desired level of anaesthesia not reached after 30 mins. Women turned supine with left lateral tilt after injection of main dose. Height of block tested with temperature discrimination 30 minutes after injection of main dose. All patients received a preload of 1000 ml Ringer lactate and Macrodex 500 ml 25‐30 minutes before institution of blockade. Hypotension (systolic blood pressure < 100 mmHg) was treated with volume infusion and 5‐10 mg ephedrine iv. |
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Outcomes | Number of women requiring additional analgesia during surgery was recorded. IV fentanyl supplements were given when women complained about perioperative discomfort. Number of women requiring treatment for hypotension was recorded. Number of neonates requiring supplemental oxygen after delivery was recorded. Neonates deemed to require oxygen treatment were determined by the neonatologists. No other criteria were described. |
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Notes | Sweden. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
G: gauge IM: intramuscular IV: intravenous mins: minutes