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Enrolling by Invitation

NCT Number: NCT06636864

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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

Primary outcomes

  1. QoR15 score at 24 hours after surgery

    Time frame: Day 1 after surgery

Secondary outcomes

  1. QoR15 scores 48 and 72 hours after surgery

    Time frame: Day 2and 3 after surgery

  2. Morphine consumption equivalent 24, 48, 72 hours after surgery

    Time frame: Day 1,2and 3 after surgery

  3. Rest and cough NRS scores in PACU after surgery

    Time frame: 30 minutes after surgery

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

    Time frame: Day 1,2and 3 after surgery

  5. Intraoperative opioid dosage

    Time frame: in surgery

  6. First postoperative exhaust time

    Time frame: up to one week

  7. The first time to get out of bed after surgery

    Time frame: up to one week

  8. Supplement the amount of analgesic drugs 24, 48 and 72 hours after surgery

    Time frame: Day 1,2and 3 after surgery

  9. Adverse events (dizziness, headache, nausea and vomiting, pruritus, hypotension) 24, 48, 72 hours after surgery

    Time frame: Day 1,2and 3 after surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.