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Laparoscopic Colorectal Cancer SurgeryNCT06636864

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

A study testing Intrathecal morphine, Intrathecal saline injection and TAPB in people with Laparoscopic Colorectal Cancer Surgery, run by Sun Yat-sen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Laparoscopic Colorectal Cancer Surgery
What is being tested?
Intrathecal morphine, Intrathecal saline injection and TAPB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
15 Oct 2024to 30 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

Other trials in 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. 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.

Read the 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.

Being tested
Intrathecal morphine, Intrathecal saline injection, TAPB
Keywords
Laparoscopic colorectal cancer surgery, QoR-15, Intrathecal morphine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal morphineProcedure or surgery

    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 injectionProcedure or surgery

    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.

  • TAPBProcedure or surgery

    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

Study groups in NCT06636864
Study groupRoleWhat they receive
Intrathecal morphine groupExperimentalBefore 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
Receives: Procedure: Intrathecal morphine; Procedure: TAPB
Normal saline groupActive comparatorBefore anesthesia induction, the control group received intrathecal injection of normal saline.
Receives: Procedure: Intrathecal saline injection; Procedure: TAPB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. QoR15 score at 24 hours after surgery

    Measured: Day 1 after surgery

Secondary outcomes (9)
  1. QoR15 scores 48 and 72 hours after surgery

    Measured: Day 2and 3 after surgery

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

    Measured: Day 1,2and 3 after surgery

  3. Rest and cough NRS scores in PACU after surgery

    Measured: 30 minutes after surgery

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

    Measured: Day 1,2and 3 after surgery

  5. Intraoperative opioid dosage

    Measured: in surgery

  6. First postoperative exhaust time

    Measured: up to one week

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

    Measured: up to one week

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

    Measured: Day 1,2and 3 after surgery

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

    Measured: Day 1,2and 3 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start15 Oct 2024
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636864
Sponsor's protocol ID
2024-FXY-302
Status last verified
Dec 2024
First submitted
8 Oct 2024
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Feb 1;161(2):124-131. doi: 10.1001/jamasurg.2025.5699.

    PubMed 41433024

Questions about this trial

What is this clinical trial studying?

A study testing Intrathecal morphine, Intrathecal saline injection and TAPB in people with Laparoscopic Colorectal Cancer Surgery, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QoR15 score at 24 hours after surgery (time frame: Day 1 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636864, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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