Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Gynecological Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSun Yat-sen University

About this trial

Minimally invasive gynecologic surgery has become the standard approach for the treatment of benign and malignant gynecologic diseases, offering the advantages of reduced surgical trauma and faster recovery. However, postoperative pain remains a major barrier to optimal recovery, with up to 40% of patients experiencing moderate to severe pain within the first 24 hours after laparoscopic procedures. Laparoscopic gynecologic surgery typically induces both somatic pain from abdominal wall incisions and visceral pain caused by peritoneal traction and pneumoperitoneum, making effective analgesia challenging. Transversus abdominis plane block (TAPB) is commonly used to control somatic incisional pain but provides limited relief of visceral pain, often resulting in increased opioid consumption and opioid-related adverse effects such as dizziness and postoperative nausea and vomiting. Intrathecal morphine (ITM) offers potent and long-lasting visceral analgesia with minimal systemic opioid requirements and has demonstrated safety and efficacy across multiple surgical settings. The complementary analgesic mechanisms of TAPB and intrathecal morphine suggest that their combination may enhance postoperative recovery by improving pain control while reducing opioid use.

The objective of this randomized controlled trial is to evaluate whether the combination of intrathecal morphine and TAPB improves the quality of recovery after laparoscopic gynecologic surgery compared with TAPB alone. This study aims to provide high-quality clinical evidence to guide the development of an optimized multimodal analgesia strategy for patients undergoing minimally invasive gynecologic procedures.

Eligibility criteria

Qualifiers

Female patients aged ≥18 years.

Scheduled for elective laparoscopic gynecological surgery under general anesthesia.

American Society of Anesthesiologists (ASA) physical status I-III.

Able to provide written informed consent.

Disqualifiers

Contraindications to neuraxial anesthesia.

Allergy to morphine or local anesthetics.

Long-term opioid use (>20 morphine milligram equivalents per day).

Baseline NRS pain score >3.

Trial design

Treatments tested in this trial

  • Intrathecal morphine group
  • TAPB
  • Intrathecal saline injection
  • TAPB

Treatment groups

252 Participants
are divided into 2 treatment groups

Sponsors and collaborators