NCT02577809

Intrathecal Opioid Study

An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

1. To evaluate the effect of three different intrathecal opioid mixtures on post-operative pain experiences in women who have undergone caesarean section surgery, relating specifically to: 1. Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery 2. Pain scores at two time points (12 hours and 24 hours) after surgery 3. Sedation scores at two time points (12 hours and 24 hours) after surgery 4. Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery 5. Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery 2. To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Morphine100	100mcg added to the spinal anaesthetic
DRUG	Morphine50	50mcg added to the spinal anaesthetic
DRUG	Fentanyl	25mcg Fentanyl added to the spinal anaesthetic
DRUG	Hyperbaric Bupivicaine	1.8ml 0.5% spinal bupivicaine with dextrose
DRUG	Indomethacin	100mg Indomethacin suppository

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-10-16
• Last updated: 2015-10-16

Locations

1 site across 1 country: South Africa