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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intrathecal morphine group

    Procedure/Surgery

    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.

  • TAPB

    Procedure/Surgery

    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 saline injection

    Procedure/Surgery

    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.

  • TAPB

    Procedure/Surgery

    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.

Treatment groups

252 Participants
are divided into 2 treatment groups
Group A: Intrathecal morphine groupExperimental treatment 2 interventions
Group B: Normal saline groupActive comparator 2 interventions

Trial outcomes

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.

Time frame
24 hours after surgery

Secondary outcomes

1

QoR-15 score at 48 and 72 hours postoperatively

The QoR-15 total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

Time frame
48 and 72 hours after surgery
2

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

Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.

Time frame
24, 48, and 72 hours after surgery
3

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

Pain intensity will be assessed using the NRS, ranging from 0 to 10, with higher scores indicating greater pain intensity

Time frame
30 minutes after surgery
4

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

Time frame
24, 48, and 72 hours after surgery

Other outcomes

Sponsors and contacts

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