Comparison of Epidural Oxycodone and Epidural Morphine

Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: Opioid administration oxycodone; Drug: Opioid administration morphine

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxycodone; Epidural oxycodone 3mg single dose as opioid administration	Drug: Opioid administration oxycodone; Epidural administration single dose through epidural catheter; Other Names: Epidural Opioid
Active Comparator: Morphine; Epidural morphine 3mg single dose as opioid administration	Drug: Opioid administration morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus	Incidence of pruritus at 24 hours	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain score at 24 hours on using 0 to 10 scale	1 day
Nausea and Vomiting	Incidence of Nausea and Vomiting at 24 hours	1 day

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 26, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pruritus
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Morphine; Oxycodone; Analgesics, Opioid
• Other Study ID Numbers: 2013/321/D