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

RecruitingNAAges 18 Years - 80 YearsAllTianjin First Central Hospital
NCT07651722 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 + Oxycodo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients scheduled to undergo elective major abdominal surgery, specifically small bowel or colorectal resections. * Aged between 18 and 80 years (inclusive). * American Society of Anesthesiologists (ASA) physical status I, II, or III. * Capable of understanding the study procedures, cooperating with postoperative pain/recovery assessments (e.g., VAS, QoR-15, I-FEED), and providing written informed consent prior to surgery. Exclusion Criteria: * History of significant neuropsychiatric disorders, including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, that may interfere with pain perception or cognitive evaluation. * History of alcohol abuse or chronic opioid/analgesic dependence. * Severe, uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg). * Severe cardiac, hepatic, renal, or pulmonary dysfunction that poses a high surgical/anesthetic risk or alters drug metabolism. * Pregnant or lactating women. * Known allergy, hypersensitivity, or contraindications to any of the study medications, including local anesthetics (ropivacaine, bupivacaine) or opioids (sufentanil, oxycodone).
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What it tests

  • ropivacaine hydrochloride
  • Liposomal bupivacaine (LB)
  • Sufentanil citrate
  • oxycodone
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Where

1 site
Tianjin First Central Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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