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Comparison of Epidural Oxycodone and Epidural Morphine

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ClinicalTrials.gov Identifier: NCT02277678
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pruritus Drug: Opioid administration oxycodone Drug: Opioid administration morphine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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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 Name: Epidural Opioid
Active Comparator: Morphine
Epidural morphine 3mg single dose as opioid administration
 Drug: Opioid administration morphine


Outcome Measures
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Primary Outcome Measures :
  1. Pruritus [ Time Frame: 1 day ]
    Incidence of pruritus at 24 hours


Secondary Outcome Measures :
  1. Pain [ Time Frame: 1 day ]
    Pain score at 24 hours on using 0 to 10 scale

  2. Nausea and Vomiting [ Time Frame: 1 day ]
    Incidence of Nausea and Vomiting at 24 hours


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277678


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Ban L Sng, FANZCA KK Women's and Children's Hospital
More Information
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02277678    
Other Study ID Numbers: 2013/321/D
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Keywords provided by KK Women's and Children's Hospital:
Pruritus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Morphine
Oxycodone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents