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

Официальное название

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

Обзор

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

Вмешательства

• Препарат ropivacaine hydrochloride
  0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
• Препарат Liposomal bupivacaine (LB)
  266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
• Препарат Sufentanil citrate
  Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
• Препарат oxycodone
  Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.

Первичные конечные точки

• Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days [Срок оценки: Postoperative Day 1 to Postoperative Day 7]

Вторичные конечные точки (8)

• Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively [Срок оценки: Resting pain and activity-induced pain were assessed using a numerical rating scale (NRS, 0-10; higher scores indicate more severe pain) at predetermined time points, and the time-weighted average score was calculated for the 72-hour postoperative period]
• TWA of Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score within Postoperative 72h [Срок оценки: Postoperative 24h,48h,72h]
• Total opioid dose (morphine equivalent) within 72 hours postoperatively [Срок оценки: 0-72 hours after surgery]
• Incidence of Prolonged Postoperative Ileus (PPOI) [Срок оценки: Within postoperative 7 days]
• First Flatus & First Defecation Time [Срок оценки: The time from the end of surgery to the first flatus and the first defecation was recorded. The maximum follow-up duration was 7 days postoperatively.]
• First Ambulation Time & Length of Hospital Stay(LOS) [Срок оценки: Time from the end of surgery to first ambulation and time to hospital discharge after surgery were recorded, with follow-up capped at 2 weeks postoperatively.]
• QoR-15 Recovery Score [Срок оценки: Postoperative day 1，Postoperative day 2 ，Postoperative day 3]
• Incidence of Postoperative Adverse Events [Срок оценки: Postoperative Day 1 - Day7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin First Central Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07651722 · TJH-2026-99

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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