CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

• Status: Completed
• Trial end date: 2018-04-25
• Target enrollment: 0
• Participant gender: Female

Summary

Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied.

The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available.

Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared.

NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sarah Beckley
• Treatments: Bupivacaine; Fentanyl; Morphine

Criteria

Inclusion Criteria:

• Parturients in active labour >4cm dilatation

• American Society of Anesthesiologists (ASA) classification I and II

Exclusion Criteria:

• Significant co-morbidities like uncontrolled hypertension or diabetes

• Maternal hemorrhage with hypotension

• Significant bleeding/clotting disorders