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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Open Abdominal Surgery

In brief

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.

Key facts

Study ID

NCT07575321

Run by

Sun Yat-sen University

People needed

756

Starts

2026-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Full record on ClinicalTrials.gov

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