About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Coagulopathy or bleeding disorders.
Opioid dependence or chronic opioid use.
Allergy or contraindication to local anesthetics or morphine.
Contraindication to neuraxial (spinal) anesthesia.
Trial design
Parallel
Treatments tested in this trial
Intrathecal Morphine
DrugA single dose of 200 µg preservative-free morphine will be administered intrathecally at the L3-L4 interspace prior to induction of general anesthesia. The injection is performed using a 25G spinal needle. This intervention aims to provide prolonged early postoperative analgesia in patients undergoing laparoscopic hysterectomy.
Trocar-Site Bupivacaine Infiltration
DrugAt the end of laparoscopic hysterectomy, 5 mL of 0.25% bupivacaine will be infiltrated into each trocar site. This intervention targets somatic pain originating from trocar entry points. It is administered only in the Local Anesthesia (LA) Group. The total dose of bupivacaine from all applications will remain within recommended safety limits.
Intraperitoneal Bupivacaine spray
DrugA total of 40 mL of 0.25% bupivacaine will be instilled intraperitoneally after completion of the surgical procedure. This intervention is designed to reduce visceral and peritoneal irritation-related pain following laparoscopic hysterectomy. The combined bupivacaine dose from trocar-site infiltration and intraperitoneal instillation will not exceed 2 mg/kg.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative quality of recovery at 24 hours measured by QoR-15
The primary outcome is the overall postoperative recovery quality at 24 hours, assessed using the 15-item Quality of Recovery questionnaire (QoR-15). This scale evaluates physical comfort, emotional state, physical independence, psychological support, and pain to provide a comprehensive patient-centered measure of recovery.
Secondary outcomes
Time to first rescue opioid requirement
Duration (in hours) from the end of surgery to the first administration of rescue opioid (oxycodone 5 mg) for postoperative pain relief.
Total opioid consumption within 24 hours
Total amount of rescue opioid consumed by the patient within the first 24 hours after surgery, expressed in milligrams.
Time to first mobilization
Time (in hours) from the end of surgery until the patient is able to ambulate independently for the first time postoperatively.
Time to first bowel movement
Time (in hours) from the end of surgery until the patient reports the first postoperative bowel movement.
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