Comparison of Epidural Oxycodone and Epidural Morphine

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Pruritus

Treatments: Drug: Opioid administration oxycodone; Drug: Opioid administration morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02277678

2013/321/D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Oxycodone

Experimental group

Description:

Epidural oxycodone 3mg single dose as opioid administration

Treatment:

Drug: Opioid administration oxycodone

Morphine

Active Comparator group

Description:

Epidural morphine 3mg single dose as opioid administration

Treatment:

Drug: Opioid administration morphine