Itching after low (0.1 mg) versus standard (0.2 mg) spinal morphine for cesarean delivery
Official title: Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 and 0.2 Milligrams in Cesarean Section: A Randomized Clinical Trial
Run by Khon Kaen University · NCT07054775 · Data updated 2026-11-12
This test sees if using a lower dose of spinal morphine (0.1 mg) instead of the standard 0.2 mg reduces itching for pregnant women having a planned cesarean while keeping pain controlled.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 69 (estimated) |
| Sponsor | Khon Kaen University Academic / other |
| Locations | 2 sites (Khon Kaen and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | October 31, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | July 8, 2025 |
| Trial ID | NCT07054775 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18–45 with full-term, non-complicated pregnancies scheduled for non-emergency cesarean delivery and ASA I–III who are not using recent antihistamines and have no contraindications to spinal anesthesia are ideal candidates.
✕Probably not a fit
Women with contraindications to spinal anesthesia, emergency cesarean delivery, BMI ≥40, active skin disease or recent antihistamine use are unlikely to be eligible or to benefit from the dose comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional Phase 4 study compares two doses of intrathecal morphine given with spinal anesthesia for planned cesarean section—0.1 mg versus the usual 0.2 mg. Eligible pregnant women receive spinal anesthesia that includes one of the two morphine doses and are monitored during and after surgery for pruritus requiring treatment, pain control, and other side effects such as nausea, vomiting, and respiratory depression. The primary outcome is the incidence of pruritus requiring treatment; secondary outcomes include pain scores and other adverse events. The trial is conducted at the Faculty of Medicine, Khon Kaen University in Thailand and follows standard perioperative monitoring and rescue protocols.
Why it matters
Potential benefit: If successful, the lower morphine dose could reduce the frequency of itching after cesarean while maintaining effective postoperative pain relief.
How similar studies have gone: Prior clinical reports and randomized trials have suggested that lower intrathecal morphine doses often reduce pruritus while preserving analgesia, although results across studies are variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • Pregnant women aged 18-45 years * Full-term pregnancy * Scheduled for non-emergency cesarean section * ASA physical status I-III * Non-complicated pregnancy Exclusion Criteria: * Contraindication to spinal anesthesia or study drugs * Refusal to participate in the study * BMI ≥ 40 kg/m² * History of systemic skin disease or current itchy skin condition * Use of antihistamines or anti-pruritic medications within 3 days prior to surgery
Where it's running
-
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand Recruiting -
Thepakorn Sathitkarnmanee
Khon Kaen, Thailand Recruiting
Study contacts
- Study coordinator: Thepakorn Sathitkarnbmanee
- Email: thepakorns@gmail.com
- Phone: 66-81-9547622
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.