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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Liposomal bupivacaine (LB): 266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.

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

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

Study 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

Primary outcome measure(s)

• Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days — Postoperative Day 1 to Postoperative Day 7
  The I-FEED score was recorded daily on days 1 through 7; the area under the curve (AUC) of the consecutive I-FEED scores within 7 days postoperatively was calculated to comprehensively assess the recovery of postoperative gastrointestinal function. A higher score indicates poorer recovery of gastrointestinal function. An I-FEED score \> 6 indicates severe gastrointestinal dysfunction.

Trial sites (1)

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