Spinal (intrathecal) morphine versus local bupivacaine for recovery after laparoscopic hysterectomy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT07232108 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Erzurum
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.