Effect of Intrathecal Morphine on Quality of Recovery After Laparoscopic Colorectal Cancer Surgery

NCT06636864 | Enrolling By Invitation

• 1 other identifier: 2024-FXY-302
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the second most common tumor in women and the third most common tumor in men, accounting for approximately 10% of tumors diagnosed and tumor-related deaths worldwide each year. Laparoscopic resection has become the standard of colorectal cancer surgery, and its main advantages are to shorten the length of hospital stay, reduce postoperative pain, and accelerate patient recovery. However, it has been reported that about 49% of patients undergoing laparoscopic colorectal cancer surgery still have moderate to severe postoperative pain. The insertion of abdominal drainage tube will increase the degree of postoperative pain, especially when patients take deep breaths, exercise or cough, which will increase the demand for postoperative opioids and reduce the quality of postoperative recovery. How to further reduce the postoperative pain of patients, reduce the dosage of opioids, shorten the length of hospital stay, promote the rapid recovery of patients and improve patient satisfaction are our concerns. Intrathecal morphine can provide a good analgesic effect on visceral pain. At present, intrathecal morphine has become a new method of postoperative analgesia, which is used in thoracic, abdominal and obstetrics and gynecology operations. The objective of this study was to investigate the effect of intrathecal morphine on the quality of recovery after laparoscopic colon cancer surgery.

Conditions

Laparoscopic Colorectal Cancer Surgery

Keywords

Laparoscopic colorectal cancer surgery; QoR-15; Intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• QoR15 score at 24 hours after surgery

  Day 1 after surgery

Secondary Outcomes (9)

• QoR15 scores 48 and 72 hours after surgery

  Day 2and 3 after surgery

• Morphine consumption equivalent 24, 48, 72 hours after surgery

  Day 1，2and 3 after surgery

• Rest and cough NRS scores in PACU after surgery

  30 minutes after surgery

• NRS scores at rest, deep breathing, activity, and cough 24, 48, and 72 hours after surgery

  Day 1，2and 3 after surgery

• Intraoperative opioid dosage

  in surgery

Study Arms (2)

Intrathecal morphine group

EXPERIMENTAL

Before induction of anesthesia, the experimental group received intrathecal morphine in the lumbar segment (L3/4).For our preliminary clinical application, the intrathecal morphine was 3ug/kg

Procedure: Intrathecal morphine; Procedure: TAPB

Normal saline group

ACTIVE COMPARATOR

Before anesthesia induction, the control group received intrathecal injection of normal saline.

Procedure: Intrathecal saline injection; Procedure: TAPB

Interventions

Intrathecal morphine PROCEDURE

The patient was asked to lie on the side, the needle insertion point was located under the guidance of color ultrasound, and after local anesthesia, the needle was inserted into the subarachnoid space at the puncture point and morphine was injected.

Intrathecal morphine group

Intrathecal saline injection PROCEDURE

After the patient was asked to lie on his side, the injection point was determined under the guidance of color ultrasound. After local anesthesia, the needle was injected into the subarachnoid space and then normal saline was injected.

Normal saline group

TAPB PROCEDURE

The patient was in a supine position. The rectus muscle was confirmed to be warping under the guidance of color photography, and the needle was injected with bupivacaine liposomes

Intrathecal morphine group; Normal saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparoscopic colorectal cancer surgery under tracheal intubation and general anesthesia is intended
• Agreed to use intravaginal morphine injection and bupivacaine liposomal plane block of transversal muscle after surgery
• ASA Grade I - III
• Over 18 years of age

You may not qualify if:

• Preoperative accident or subjective refusal of surgery
• Nervous system dysfunction
• Contraindications to intraspinal anesthesia
• Preoperative opioid use history
• Patients with abnormal preoperative pain and pain score (NRS) \>3

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Zheng L, Lu Y, Lu X, You L, Yu C, Lai J, Xu M, Xie M, Xiao Y, Lai R. Intrathecal Morphine for Enhanced Recovery After Laparoscopic Colorectal Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Dec 23:e255699. doi: 10.1001/jamasurg.2025.5699. Online ahead of print.

  PMID: 41433024 DERIVED

MeSH Terms

Interventions

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

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: October 8, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)