Spinal (intrathecal) morphine versus local bupivacaine for recovery after laparoscopic hysterectomy
Official title: Effects of Intrathecal Morphine Compared With Trocar-Site Infiltration and Intraperitoneal Bupivacaine on Postoperative Quality of Recovery and Inflammatory Markers After Laparoscopic Hysterectomy: A Prospective, Randomized, Double-Blind Controlled Trial
Run by Ataturk University · NCT07232108 · Data updated 2026-11-12
This will test whether a single spinal injection of morphine or local bupivacaine given at trocar sites and inside the abdomen better reduces pain and improves recovery for women having elective laparoscopic hysterectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 64 (estimated) |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 2, 2026 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07232108 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–65 scheduled for elective laparoscopic hysterectomy for benign gynecologic conditions, ASA physical status I–III, who can give written informed consent are eligible.
✕Probably not a fit
Patients with contraindications to neuraxial or local anesthesia, chronic opioid dependence, severe renal or hepatic dysfunction, pregnancy, or breastfeeding are excluded and unlikely to benefit from the trial interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a prospective, randomized, double-blind design, patients undergoing elective laparoscopic hysterectomy are assigned to receive either 200 µg intrathecal morphine before general anesthesia or trocar-site infiltration plus intraperitoneal bupivacaine during surgery, with all patients managed under a standardized anesthetic protocol. The primary patient-centered outcome is the Quality of Recovery (QoR-15) score, with additional measurement of postoperative pain scores, opioid consumption, opioid-related side effects, and hematologic inflammatory markers. Respiratory and hemodynamic monitoring is emphasized after intrathecal morphine, and follow-up assessments occur during the immediate postoperative period. The trial directly compares a central neuraxial analgesic technique with peripheral local-anesthetic approaches to identify which strategy best supports early recovery after minimally invasive hysterectomy.
Why it matters
Potential benefit: If successful, the preferred approach could provide better early pain relief, reduce opioid requirements, and speed recovery after laparoscopic hysterectomy.
How similar studies have gone: Previous randomized trials have shown that intrathecal morphine and intraperitoneal/trocar-site bupivacaine each reduce early postoperative pain and opioid use after minimally invasive gynecologic surgery, though direct head-to-head comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients aged 18-65 years. * Elective laparoscopic hysterectomy planned for benign gynecological conditions. * American Society of Anesthesiologists (ASA) physical status I-III. * Ability to provide written informed consent. Exclusion Criteria: * Coagulopathy or bleeding disorders. * Opioid dependence or chronic opioid use. * Allergy or contraindication to local anesthetics or morphine. * Contraindication to neuraxial (spinal) anesthesia. * History of chronic pain syndromes. * Severe renal or hepatic dysfunction. * Pregnancy or breastfeeding.
Where it's running
-
Ataturk University
Erzurum, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Ayşenur Dostbil, Principal Investigator — Ataturk University Department of Anesthesiology and Reanimation
- Study coordinator: Ayşenur Dostbil, Associate Professor
- Email: adostbil@hotmail.com
- Phone: +90-533-367-66-96
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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.