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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Laparoscopic Colorectal Cancer Surgery
• Intervention / Treatment: Procedure: Intrathecal morphine; Procedure: TAPB; Procedure: Intrathecal saline injection

Detailed Description

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.

The anesthesia scheme was endotracheal intubation general anesthesia combined with bupivacaine liposome plane block of transverse abdominal muscle, experimental group combined with intrathecal morphine, control group injected with intrathecal saline. Heart rate, electrocardiogram, pulse oxygen saturation, noninvasive blood pressure, and end-expiratory partial carbon dioxide pressure (ETCO2) were routinely monitored after entry. Before anesthesia induction, the experimental group received lumbar morphine (L3/4). Based on the literature and our previous clinical application, the intrathecal morphine was 3ug/kg. Control group received intrathecal injection of normal saline. General anesthesia was induced by intravenous injection of dexmedetomidine (0.5ug/kg), cyclopofol (0.4mg/kg), remifentanil (TCI4ng/ml) and rocuronium (0.6mg/kg), followed by tracheal intubation. Bupivacaine liposome plane block of transverse abdominal muscle was performed in both groups, bupivacaine liposome injection (20ml: 266mg) was diluted with 0.9% sodium chloride solution from 20ml to 40ml, and 10ml diluent solution was injected into the left and right abdominal subcostoal approach and lateral approach under ultrasound guidance. Anesthesia was maintained with 1-1.3MAC desflurane, remifentanil, sufentanil, cis-atracurium, and vasoactive agents as needed. Intraoperative opioid dosage was recorded. Patients in both groups received intravenous controlled analgesia, 150mg morphine with 0.9% sodium chloride solution to 150ml intravenous analgesia pump. The background dose is 0ml/h, the single patient-controlled analgesia dose is 1ml, and the locking time is 6 minutes to manage fulminant pain. When adverse events such as hypotension occur, appropriate accelerated fluid rehydration is given while makingWith vasoactive drugs, the nurse (who did not participate in the study) was asked to reduce the parameters of the intravenous analgesic pump to 1/2 of the original, and if the symptoms persisted, the analgesic pump was turned off and the study was terminated. The main outcome was QoR15 score 24 hours after operation.

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal saline group; Before anesthesia induction, the control group received intrathecal injection of normal saline.	Procedure: TAPB; 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; Procedure: Intrathecal saline injection; 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.
Experimental: Intrathecal morphine group; 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; 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.; Procedure: TAPB; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QoR15 score at 24 hours after surgery	Day 1 after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
First postoperative exhaust time	up to one week
The first time to get out of bed after surgery	up to one week
Supplement the amount of analgesic drugs 24, 48 and 72 hours after surgery	Day 1，2and 3 after surgery
Adverse events (dizziness, headache, nausea and vomiting, pruritus, hypotension) 24, 48, 72 hours after surgery	Day 1，2and 3 after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intrathecal morphine; QoR-15; Laparoscopic colorectal cancer surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; 1,3-bis(4-amidinophenoxy)-2-(4-amidinophenoxymethyl)ethylpropane
• Other Study ID Numbers: 2024-FXY-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No