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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Ataturk University
RECRUITING
Erzurum
Contact Information
Primary
Ayşenur Dostbil, Associate Professor
adostbil@hotmail.com
+90-533-367-66-96
Backup
Mehmet Akif Yılmaz, assistant doctor
mehmetakifyilmaz025@gmail.com
+90-534-653-35-39
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-06-02
Participants
Target number of participants: 64
Treatments
Experimental: Intrathecal Morphine Group
Participants in this arm will receive 200 µg of preservative-free intrathecal morphine administered at the L3-L4 interspace prior to induction of general anesthesia. This intervention is intended to provide early postoperative analgesia following laparoscopic hysterectomy.
Active_comparator: Local Anesthesia Group
Participants in this arm will receive 0.25% bupivacaine infiltration (5 mL at each trocar site) and 40 mL of 0.25% bupivacaine administered intraperitoneally at the end of surgery. The total dose of bupivacaine will not exceed 2 mg/kg. This technique aims to reduce postoperative somatic and visceral pain after laparoscopic hysterectomy.
Related Therapeutic Areas
Sponsors
Leads: Ataturk University

This content was sourced from clinicaltrials.gov