Intrathecal Opioid Study

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an interventional drug trail to evaluate the effect of different intrathecal opioids on post-operative pain experiences in women who have undergone caesarean section surgery.

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

Details

• Lead Sponsor: University of Witwatersrand, South Africa
• Treatments: Bupivacaine; Fentanyl; Indomethacin; Morphine

Criteria

Inclusion Criteria:

• All patients > 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital

Exclusion Criteria:

• Pre-operative:

b) Patient refusal or inability to give informed consent c) Severe pre-eclampsia d) Eclampsia e) Patient unable to understand how to use the Patient Controlled Analgesia (PCA) pump, after appropriate counselling and training

• Intra-operative:

a) Obstetric Complications: i) Post-partum Haemorrhage ii) Ruptured Uterus iii) Still Birth b) Conversion to general anaesthesia intra-operatively c) Administration of supplementary intravenous opioid analgesics

• Post-operative:

1. Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities

2. Patients who require ICU or High care admission postoperatively for any intra-operative complications