Comparison of Epidural Oxycodone and Epidural Morphine
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 4, 2015
September 1, 2015
1.3 years
October 26, 2014
September 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pruritus
Incidence of pruritus at 24 hours
1 day
Secondary Outcomes (2)
Pain
1 day
Nausea and Vomiting
1 day
Study Arms (2)
Oxycodone
EXPERIMENTALEpidural oxycodone 3mg single dose as opioid administration
Morphine
ACTIVE COMPARATOREpidural morphine 3mg single dose as opioid administration
Interventions
Epidural administration single dose through epidural catheter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, Singapore, 229899, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ban L Sng, FANZCA
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2014
First Posted
October 29, 2014
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 4, 2015
Record last verified: 2015-09