Comparison of Epidural Oxycodone and Epidural Morphine

Phase 3

Completed

• Conditions: Pruritus
• Interventions: Drug: Opioid administration oxycodone; Drug: Opioid administration morphine

• Registration Number: NCT02277678
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

The primary objectives of this study are to compare the efficacy of pain relief between epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean section and to compare the incidence and severity of pruritus. Secondary objectives are to compare other side effects of epidural administered oxycodone and morphine (nausea and vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean sections.

Detailed Description

Undesirable side effects such as pruritus and nausea are common with epidural morphine and are thought to be due to mu-opioid receptor stimulation at the supra-spinal level. Recent studies of epidural oxycodone for abdominal and gynaecological surgery have shown that it is as effective as morphine with fewer side effects by this route. This has not been established in patients undergoing caesarean section. Oxycodone is a semi-synthetic opioid derivative that resembles morphine structurally and has similar lipid solubility. It has been reported that the analgesic action of oxycodone is more rapid in onset when compared with morphine and is mediated by kappa-opioid receptors in the spinal cord. The significance of our study would be to establish that epidural oxycodone reduces the side effects of pruritus of epidural morphine whilst still maintaining similar analgesia.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-10-26
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status 1-2,
• aged between 21 to 50 years undergoing a term elective caesarean section and
• had consented for combined spinal-epidural (CSE) anaesthesia

Exclusion Criteria

• concurrent opioid therapy,
• contraindications to CSE anaesthesia or any of the study medications,
• a history of pre-existing nausea and vomiting,
• failure to identify intrathecal space at time of anaesthesia,
• inadvertent dural puncture with the epidural needle and
• conversion of regional anaesthesia to general anaesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Opioid administration oxycodone	Epidural oxycodone 3mg single dose as opioid administration
Morphine	Opioid administration morphine	Epidural morphine 3mg single dose as opioid administration

Primary Outcome Measures

Name	Time	Method
Pruritus	1 day	Incidence of pruritus at 24 hours

Secondary Outcome Measures

Name	Time	Method
Nausea and Vomiting	1 day	Incidence of Nausea and Vomiting at 24 hours
Pain	1 day	Pain score at 24 hours on using 0 to 10 scale

Trial Locations

Locations (1)

KK Women's and Children's Hospital; 🇸🇬 Singapore, Singapore