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. 2004 Apr 19;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2

Helbo‐Hansen 1988.

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: 
 One patient in spinal group excluded due to spontaneous labour. Included in intention‐to treat analysis.
Blinding of outcome assessment: 
 Not mentioned.
Losses to follow up: 
 None.
Participants Inclusion criteria: 
 40 healthy women without maternal or fetal complications booked for elective caesarean section in a university hospital in Denmark.
Exclusion criteria: 
 None mentioned.
Number lost to follow up: 
 None.
Interventions Spinal anaesthesia: 
 2.6 ml plain bupivacaine 0.5% injected in left lateral position through 26 gauge spinal needle at L3‐4 interspace. Women then placed supine with 15 degrees left lateral tilt within 2 minutes after injection.
Epidural anaesthesia: 
 With epidural catheter via Tuohy needle at L2‐3 interspace, inserted in sitting position. Test dose of 3 ml 0.5% bupivacaine, followed by initial dose of 10 ml injected 5 minutes later. Women were then placed in the left lateral position after another 5 minutes. Further boluses of 0.5% bupivacaine were given until anaesthetic level had reached T6 bilaterally. Women then turned supine with 15 degrees left lateral tilt for operation.
Ephedrine 5‐10 mg was given if systolic blood pressure fell below 100 mmHg or > 30% of baseline. All women received a fluid preload and were given prophylactic ephedrine, but this was not standardised between the spinal and epidural groups.
All women were offered iv pethidine during operation if they showed signs of discomfort.
Postoperatively, patients were reviewed daily and pethidine im was given on request.
Outcomes Number of women failing to achieve adequate anaesthesia to begin surgery and the reasons why were recorded.
Treatment for hypotension was recorded as doses used in each group and not number of women treated.
Pain experienced during the operation was recorded using a visual analogue scale. There was no record of iv pethidine use due to "excellent analgesia" during surgery.
Postoperatively, the number of women receiving pethidine im for analgesia were recorded.
Neonates were assessed but no interventions were mentioned.
Notes Denmark.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear