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Recruiting NCT07232108

Intrathecal Morphine Versus Trocar-Site and Intraperitoneal Bupivacaine for Quality of Recovery After Laparoscopic Hysterectomy

Trial Parameters

Condition Postoperative Pain Management
Sponsor Ataturk University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 64
Sex FEMALE
Min Age 18 Years
Max Age 65 Years
Start Date 2025-12-01
Completion 2026-06-01
Interventions
Intrathecal MorphineTrocar-Site Bupivacaine InfiltrationIntraperitoneal Bupivacaine spray

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.

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