Comparison of Epidural Oxycodone and Epidural Morphine

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277678
• Other study ID #: 2013/321/D
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2014
• Last updated: September 3, 2015
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Opioid administration oxycodone
Epidural administration single dose through epidural catheter
• Opioid administration morphine

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus	Incidence of pruritus at 24 hours	1 day	No
Secondary	Pain	Pain score at 24 hours on using 0 to 10 scale	1 day	No
Secondary	Nausea and Vomiting	Incidence of Nausea and Vomiting at 24 hours	1 day	No