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Completed

NCT Number: NCT02277678

Comparison of Epidural Oxycodone and Epidural Morphine

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.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid administration oxycodone

Drug

Epidural administration single dose through epidural catheter

Other names: Epidural Opioid

Opioid administration morphine

Drug

Primary outcomes

  1. Pruritus

    Time frame: 1 day

    Incidence of pruritus at 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2014
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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