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

Official title

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

Overview

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

Interventions

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

Primary outcome measures

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

Secondary outcome measures (8)

• Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively [Time frame: 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 [Time frame: Postoperative 24h,48h,72h]
• Total opioid dose (morphine equivalent) within 72 hours postoperatively [Time frame: 0-72 hours after surgery]
• Incidence of Prolonged Postoperative Ileus (PPOI) [Time frame: Within postoperative 7 days]
• First Flatus & First Defecation Time [Time frame: 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) [Time frame: 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 [Time frame: Postoperative day 1，Postoperative day 2 ，Postoperative day 3]
• Incidence of Postoperative Adverse Events [Time frame: Postoperative Day 1 - Day7]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin First Central Hospital — Tianjin

Identifiers

NCT: NCT07651722 · TJH-2026-99

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗