RecruitingNot ApplicableNCT07651722

Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery

Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Function in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial


Sponsor

Tianjin First Central Hospital

Enrollment

132 participants

Start Date

Jun 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Rationale and Objective: The purpose of this study is to evaluate the clinical efficacy and safety of a novel multimodal analgesia regimen, combining transversus abdominis plane block (TAPB) with patient-controlled intravenous analgesia (PCIA), in improving postoperative gastrointestinal function recovery in patients undergoing major abdominal surgery. Study Design and Interventions: This is a prospective, single-center, randomized, double-blind, parallel-controlled trial. A total of 132 eligible patients (aged 18-80 years, ASA I-III, scheduled for elective small bowel or colorectal surgery) will be randomly allocated to one of three groups (n = 44 per group) to receive distinct postoperative analgesia regimens: Group R-S: 0.375% Ropivacaine TAPB + Sufentanil PCIA; Group LB-S: 266 mg Liposomal Bupivacaine TAPB + Sufentanil PCIA; Group LB-O: 266 mg Liposomal Bupivacaine TAPB + Oxycodone PCIA. Primary Outcome: The primary outcome is the area under the curve (AUC) of the I-FEED scoring system within the first 7 postoperative days, which comprehensively reflects the overall trajectory of gastrointestinal function recovery. Hypothesis: The investigators hypothesize that the combination of long-acting Liposomal Bupivacaine TAPB (for prolonged somatic pain relief) and Oxycodone PCIA (for precise visceral pain control via dual u and k receptor agonism) will synergistically attenuate the perioperative stress-inflammatory response. Consequently, this regimen is expected to significantly mitigate postoperative ileus (POI) and accelerate the recovery of gastrointestinal motility


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Liposomal bupivacaine (LB), a drug called Sufentanil citrate, and others for people with postoperative ileus and postoperative pain. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGropivacaine hydrochloride

0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.

DRUGLiposomal bupivacaine (LB)

266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.

DRUGSufentanil citrate

Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.

DRUGoxycodone

Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.


Locations(1)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

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NCT07651722


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