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

NCT07322029 | Not Yet Recruiting

• 1 other identifier: 2025-FXY-311
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Gynecological Surgery

Keywords

laparoscopic gynecological surgery; QoR-15; Intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• QoR-15 score at 24 hours after surgery

  The Quality of Recovery-15 questionnaire is a validated patient-reported outcome measure assessing postoperative recovery across five domains (pain, physical comfort, emotional state, physical independence, and psychological support). Total scores range from 0 to 150, with higher scores indicating better quality of recovery.

  24 hours after surgery

Secondary Outcomes (14)

• QoR-15 score at 48 and 72 hours postoperatively

  48 and 72 hours after surgery

• Numeric Rating Scale (NRS) pain score at rest and cough at 24, 48, and 72 hours postoperatively

  24, 48, and 72 hours after surgery

• Rest and cough NRS scores in post-anesthesia care unit (PACU) after surgery

  30 minutes after surgery

• Cumulative morphine equivalent consumption at 24, 48, and 72 hours postoperatively

  24, 48, and 72 hours after surgery

• Time to first postoperative flatus

  Up to 1 week after surgery

Study Arms (2)

Intrathecal morphine group

EXPERIMENTAL

Before anesthesia induction, patients in the intervention group received an intrathecal injection of morphine at the L3-4 or L4-5 or L5-S1 interspace. The intrathecal morphine dose was 2 μg/kg.

Procedure: Intrathecal morphine group; Procedure: TAPB

Normal saline group

ACTIVE COMPARATOR

Before anesthesia induction, patients in the control group received an intrathecal injection of an equal volume of preservative-free normal saline at the L3-4 or L4-5 or L5-S1 interspace.

Procedure: Intrathecal saline injection; Procedure: TAPB

Interventions

Intrathecal morphine group PROCEDURE

With the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and intrathecal morphine was injected following confirmation of free cerebrospinal fluid flow.

Intrathecal morphine group

TAPB PROCEDURE

With the patient supine, a linear ultrasound probe was placed between the costal margin and iliac crest to identify the abdominal wall layers. Using an in-plane approach, a needle was advanced into the transversus abdominis plane, and after negative aspiration, liposomal bupivacaine was injected under direct ultrasound visualization. The block was performed bilaterally.

Intrathecal morphine group

Intrathecal saline injection PROCEDURE

With the patient in the lateral position, the puncture site was identified under ultrasound guidance. After local anesthesia, a spinal needle was advanced into the subarachnoid space, and an equal volume of preservative-free normal saline was injected after confirming cerebrospinal fluid flow.

Normal saline group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligible participants must self-identify as female, as the surgical procedures under investigation apply only to female anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cognitive impairment or inability to cooperate.
• Emergency or non-elective surgery.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangdong, Guangzhou, China

Location

MeSH Terms

Interventions

1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane

Central Study Contacts

Renchun Lai, MD

CONTACT

+8613660012343; lairch@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)