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Comparison of Epidural Oxycodone and Epidural Morphine

Primary Purpose

Pruritus

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Opioid administration oxycodone
Opioid administration morphine
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Pruritus

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxycodone

Morphine

Arm Description

Epidural oxycodone 3mg single dose as opioid administration

Epidural morphine 3mg single dose as opioid administration

Outcomes

Primary Outcome Measures

Pruritus
Incidence of pruritus at 24 hours

Secondary Outcome Measures

Pain
Pain score at 24 hours on using 0 to 10 scale
Nausea and Vomiting
Incidence of Nausea and Vomiting at 24 hours

Full Information

First Posted
October 26, 2014
Last Updated
September 3, 2015
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02277678
Brief Title
Comparison of Epidural Oxycodone and Epidural Morphine
Official Title
Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone
Arm Type
Experimental
Arm Description
Epidural oxycodone 3mg single dose as opioid administration
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Epidural morphine 3mg single dose as opioid administration
Intervention Type
Drug
Intervention Name(s)
Opioid administration oxycodone
Other Intervention Name(s)
Epidural Opioid
Intervention Description
Epidural administration single dose through epidural catheter
Intervention Type
Drug
Intervention Name(s)
Opioid administration morphine
Primary Outcome Measure Information:
Title
Pruritus
Description
Incidence of pruritus at 24 hours
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Pain
Description
Pain score at 24 hours on using 0 to 10 scale
Time Frame
1 day
Title
Nausea and Vomiting
Description
Incidence of Nausea and Vomiting at 24 hours
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban L Sng, FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore

12. IPD Sharing Statement

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Comparison of Epidural Oxycodone and Epidural Morphine

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