NCT07232108 Intrathecal Morphine Versus Trocar-Site and Intraperitoneal Bupivacaine for Quality of Recovery After Laparoscopic Hysterectomy
| NCT ID | NCT07232108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ataturk University |
| Condition | Postoperative Pain Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2025-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to compare the effects of intrathecal morphine with trocar-site infiltration and intraperitoneal bupivacaine on postoperative pain control, quality of recovery, and inflammatory response in patients undergoing elective laparoscopic hysterectomy. Laparoscopic hysterectomy is widely used for benign gynecologic conditions, but postoperative pain may result from trocar-site trauma, peritoneal irritation, and carbon dioxide insufflation. Effective postoperative analgesia can improve patient comfort, reduce opioid use, and enhance early recovery. Intrathecal morphine is known to provide potent early postoperative analgesia but may cause side effects such as nausea, vomiting, pruritus, and respiratory depression. Local anesthetic techniques, including trocar-site infiltration and intraperitoneal bupivacaine, have also been shown to reduce postoperative pain after minimally invasive gynecologic surgery. In this prospective, randomized, double-blind study, patients will be assigned to one of two groups: Intrathecal morphine (ITM) administered before induction of anesthesia; Local anesthesia group (LA) receiving trocar-site infiltration and intraperitoneal bupivacaine at the end of surgery. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, pruritus, respiratory depression, early mobilization, bowel function recovery, and perioperative inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII). The results of this trial are expected to guide clinicians in selecting optimal analgesic strategies for laparoscopic hysterectomy and to contribute to improved patient recovery and postoperative satisfaction.
Eligibility 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.
Contact & Investigator
Ayşenur Dostbil, Principal Investigator
PRINCIPAL INVESTIGATOR
Ataturk University Department of Anesthesiology and Reanimation
Frequently Asked Questions
Who can join the NCT07232108 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Postoperative Pain Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07232108 currently recruiting?
Yes, NCT07232108 is actively recruiting participants. Contact the research team at adostbil@hotmail.com for enrollment information.
Where is the NCT07232108 trial being conducted?
This trial is being conducted at Erzurum, Turkey (Türkiye).
Who is sponsoring the NCT07232108 clinical trial?
NCT07232108 is sponsored by Ataturk University. The principal investigator is Ayşenur Dostbil, Principal Investigator at Ataturk University Department of Anesthesiology and Reanimation. The trial plans to enroll 64 participants.