Intrathecal Morphine for Quality of Recovery After Open Abdominal Surgery Within an Enhanced Recovery Pathway

NCT07575321 | Not Yet Recruiting

• 1 other identifier: 2025-FXY-534
• Study Type: interventional
• Target: 756
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pain management after open abdominal surgery still faces severe challenges, with the incidence of moderate to severe pain after surgery as high as 50 - 90%. Insufficient analgesia can hinder early mobilization of patients, delay gastrointestinal function recovery, increase the risk of complications, thereby reducing the quality of patient recovery and prolonging hospital stay. The Enhanced Recovery after Surgery (ERAS) pathway has significantly improved surgical outcomes. Multimodal analgesia based on transversus abdominis plane block (TAPB) analgesia is the core of ERAS for abdominal surgery. However, the existing multimodal analgesia regimens still inade-quately control visceral pain, resulting in the failure to significantly reduce the dosage of opioid drugs, which has become a key bottleneck restricting the smooth recovery of patients. Intrathecal morphine (ITM) directly delivers the drug to the dorsal horn of the spinal cord through cerebrospinal fluid, providing potent and long-lasting visceral analgesia. Although its analgesic effect is clear, in the context of modern ERAS with routine application of TAPB, there is still insufficient evidence regarding the impact of ITM on the quality of recovery - a multi-dimensional core outcome - in patients undergoing open abdominal surgery. In addition, whether its effect is affected by key factors such as age (e.g., \>60 years) or surgical site (upper abdomen vs. lower abdomen) also remains to be clarified. Therefore, in this prospective, multicenter, randomized, double-blind, placebo-controlled trial, we aimed to evaluate whether single-dose preoperative ITM can further improve the quality of recovery in the ERAS pathway based on TAPB and to verify the efficacy differences of ITM in important subgroups.

Conditions

Open Abdominal Surgery

Keywords

Open Abdominal surgery; QoR-15; Intrathecal morphine; ERAS

Outcome Measures

Primary Outcomes (1)

• QoR15 score at 24 hours after surgery

  Lower scores represent a worse outcome.

  Day 1 after surgery

Secondary Outcomes (8)

• QoR15 scores 48 and 72 hours after surgery

  Day 2, Day 3 after surgery

• Pain score (NRS)

  Baseline, Day 1, Day 2, Day 3 after surgery

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

  Baseline, Day 1, Day 2, Day 3 after surgery

• Recovery indicators

  Up to 4 weeks after surgery

• Safety endpoints

  Day 1, Day 2, Day 3 after surgery

Study Arms (2)

Intrathecal morphine group

EXPERIMENTAL

Before induction of anesthesia, the experimental group received intrathecal morphine in the lumbar segment. 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 with the aid of ultrasound guidance. 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: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Scheduled for elective open abdominal surgery (upper or lower abdomen).
• American Society of Anesthesiologists classification I-III.
• Signed informed consent form.

You may not qualify if:

• Allergic to opioids or any drug in the trial.
• Presence of contraindications to intrathecal injection (such as abnormal coagulation function, puncture site infection, increased intracranial pressure).
• History of chronic pain, long-term use of opioids.
• Severe hepatic and renal insufficiency (Child-Pugh C grade or eGFR \< 30 mL/min).
• Severe respiratory diseases (such as non-invasive ventilation required for sleep apnea syndrome).
• Cognitive dysfunction, unable to complete the questionnaire.
• Pregnant or lactating women.
• Withdrawal criteria:
• The patient or legal representative requests withdrawal.
• Serious complications occur during the study, and continued participation is not in the best in-terest of the patient.
• Other situations where the researcher believes withdrawal is necessary.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

MeSH Terms

Interventions

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

Central Study Contacts

Renchun Lai, MD

CONTACT

+8613660012343; lairch@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The research coordinator of this center will log in to the password-protected randomization website 1 hour before the operation to obtain the random number (experimental group or control group) of the next research patient. The research coordinator will prepare the study drugs under aseptic conditions according to the random grouping and will no longer participate in the research. Experimental group (intrathecal morphine): The drug used for intrathecal injection was morphine of 3ug/kg diluted to 5ml . It was drawn into a 5-ml syringe and labeled with "Study drug for intrathecal use". Control group (placebo): The drug used for intrathecal injection was NS 5ml . It was drawn into a 5-ml syringe and labeled with "Study drug for intrathecal use". The drugs in both syringes will be placed in the spinal anesthesia tray in a sterile manner and admin-istered intrathecally by the anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share