Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07651722

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Ileus Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300384, China

Location status: Recruiting

Location contact

Wenli Yu

CONTACT

[email protected]

+86 139 2009 8326

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ropivacaine hydrochloride

Drug

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

Liposomal bupivacaine (LB)

Drug

266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.

Sufentanil Citrate

Drug

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

Oxycodone

Drug

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

Primary outcomes

  1. Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days

    Time frame: 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.

Secondary outcomes

  1. 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

    Postoperative 6h,12h,24h,48h,72h

  2. TWA of Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score within Postoperative 72h

    Time frame: Postoperative 24h,48h,72h

    The Short-form McGill Pain Questionnaire 2 (SF-MPQ-2) Score (consisting of 22 items, each scored on a scale of 0-10, with higher scores indicating more severe pain) was used to distinguish between somatic pain and visceral pain; the weighted average (TWA) of the visceral pain subscale scores was calculated.

  3. Total opioid dose (morphine equivalent) within 72 hours postoperatively

    Time frame: 0-72 hours after surgery

    The cumulative doses of sufentanil or oxycodone administered via the PCIA pump within 72 hours postoperatively, as well as the doses of opioid rescue analgesics, were converted to morphine equivalents to facilitate intergroup comparisons.

  4. Incidence of Prolonged Postoperative Ileus (PPOI)

    Time frame: Within postoperative 7 days

    PPOI defined as patients without mechanical bowel obstruction who meet ≥2 of 5 criteria after postoperative 72h: persistent PONV, intolerance to solid diet, no flatus/stool, obvious abdominal distension, daily I-FEED>6 points。

  5. 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.

    Record interval from operation completion to the first spontaneous flatus and first spontaneous defecation separately, marker of gastrointestinal peristalsis recovery.

  6. 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.

    Record time of first independent ambulation after surgery and total postoperative hospital days.

  7. QoR-15 Recovery Score

    Time frame: Postoperative day 1，Postoperative day 2 ，Postoperative day 3

    The QoR-15 questionnaire was administered on days 1, 2, and 3 postoperatively to assess overall postoperative recovery quality, with preoperative baseline scores used as covariates in the statistical analysis. The questionnaire consists of 15 items, each scored on a scale of 0 to 10, for a total score of 150. A higher score indicates better recovery quality.

  8. Incidence of Postoperative Adverse Events

    Time frame: Postoperative Day 1 - Day7

    Calculate the incidence of postoperative nausea and vomiting (PONV), constipation, dizziness, and respiratory depression (SpO₂ < 95% or respiratory rate < 10 breaths per minute) within 7 days postoperatively.

Other outcomes

  1. Serum IL-6 and Cortisol Concentrations

    Time frame: End of surgery, Postoperative Day1, Postoperative Day2

    Serum levels of interleukin-6 and cortisol were measured at three time points to assess perioperative inflammatory and surgical stress response.

  2. Serum Motilin and Gastrin Concentrations

    Time frame: End of surgery, Postoperative Day1, Postoperative Day2

    Detect serum motilin and gastrin to explore the effect of analgesic regimens on gastrointestinal endocrine function.

  3. Plasma β-Endorphin Concentration

    Time frame: End of surgery, Postoperative Day1, Postoperative Day2

    Determine plasma β-endorphin level to explore central pain modulation mechanism of multimodal analgesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke yu Zhang

CONTACT

[email protected]

+86 19861121816

Yu

CONTACT

Sponsors and collaborators

Lead sponsor

Tianjin First Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.