Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery
1 other identifier
interventional
132
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jun 2026
Shorter than P25 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 16, 2026
CompletedStudy Start
First participant enrolled
June 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
June 25, 2026
June 1, 2026
3 months
June 5, 2026
June 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
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.
Postoperative Day 1 to Postoperative Day 7
Secondary Outcomes (8)
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
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
Postoperative 24h,48h,72h
Total opioid dose (morphine equivalent) within 72 hours postoperatively
0-72 hours after surgery
Incidence of Prolonged Postoperative Ileus (PPOI)
Within postoperative 7 days
First Flatus & First Defecation Time
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.
- +3 more secondary outcomes
Other Outcomes (3)
Serum IL-6 and Cortisol Concentrations
End of surgery, Postoperative Day1, Postoperative Day2
Serum Motilin and Gastrin Concentrations
End of surgery, Postoperative Day1, Postoperative Day2
Plasma β-Endorphin Concentration
End of surgery, Postoperative Day1, Postoperative Day2
Study Arms (3)
Control Group（Ropivacaine + Sufentanil）
ACTIVE COMPARATORTAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
EXPERIMENTALTAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
EXPERIMENTALTAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
Interventions
0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300384, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wenli Yu
Tianjin First Central Hospital
Central Study Contacts
Yu
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
June 5, 2026
First Posted
June 16, 2026
Study Start
June 16, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.