PruritusPhase 3NCT02277678
Comparison of Epidural Oxycodone and Epidural Morphine
A Phase 3 study testing Opioid administration oxycodone and Opioid administration morphine in people with Pruritus, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Pruritus
- What is being tested?
- Opioid administration oxycodone and Opioid administration morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Pruritus
- Being tested
- Opioid administration oxycodone, Opioid administration morphine
- Keywords
- Pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid administration oxycodoneDrug
Also called Epidural Opioid
Epidural administration single dose through epidural catheter
Opioid administration morphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone | Experimental | Epidural oxycodone 3mg single dose as opioid administration Receives: Drug: Opioid administration oxycodone |
| Morphine | Active comparator | Epidural morphine 3mg single dose as opioid administration Receives: Drug: Opioid administration morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus
Incidence of pruritus at 24 hours
Measured: 1 day
Secondary outcomes (2)
Pain
Pain score at 24 hours on using 0 to 10 scale
Measured: 1 day
Nausea and Vomiting
Incidence of Nausea and Vomiting at 24 hours
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban L Sng, FANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277678
- Sponsor's protocol ID
- 2013/321/D
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2014
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02277678
- Acronym / sponsor ID
- 2013/321/D
- Conditions
- Pruritus
- Keywords
- Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone | Experimental | Drug: Opioid administration oxycodoneEpidural oxycodone 3mg single dose as opioid administration |
| Morphine | Active comparator | Drug: Opioid administration morphineEpidural morphine 3mg single dose as opioid administration |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid administration oxycodoneAlso: Epidural OpioidEpidural administration single dose through epidural catheter | Drug | Oxycodone |
| Opioid administration morphine | Drug | Morphine |
Primary outcome
Pruritus
Time frame: 1 day
Incidence of pruritus at 24 hours
2 secondary outcomes
Pain
Time frame: 1 day
Nausea and Vomiting
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ban L Sng, FANZCA principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Opioid administration oxycodone and Opioid administration morphine in people with Pruritus, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.