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

2026年6月22日 更新者：Wenli Yu、Tianjin First Central Hospital

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

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

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

132

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Yu

研究联系人备份

学习地点

  • 中国
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300384
        • 招聘中
        • Tianjin First Central Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control Group（Ropivacaine + Sufentanil）
TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
药品：ropivacaine hydrochloride
0.375% solution for transversus abdominis plane (TAP) local injection during surgery for postoperative analgesia.
药品：Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
实验性的：Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
药品：Sufentanil citrate
Formulated into PCIA pump for continuous intravenous infusion for postoperative patient-controlled analgesia.
药品：Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
实验性的：Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
药品：Liposomal bupivacaine (LB)
266mg single dose for TAP block local injection for postoperative pain control after abdominal surgery.
药品：oxycodone
Prepared in PCIA pump for intravenous patient-controlled analgesia after abdominal operation.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
大体时间：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.
Postoperative Day 1 to Postoperative Day 7

次要结果测量

结果测量
措施说明
大体时间
Time-Weighted Average (TWA) of Rest & Movement NRS Pain Score within 72h Postoperatively
大体时间：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
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
大体时间：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.
Postoperative 24h,48h,72h
Total opioid dose (morphine equivalent) within 72 hours postoperatively
大体时间：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.
0-72 hours after surgery
Incidence of Prolonged Postoperative Ileus (PPOI)
大体时间：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。
Within postoperative 7 days
First Flatus & First Defecation Time
大体时间：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.
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)
大体时间：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.
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
大体时间：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.
Postoperative day 1，Postoperative day 2 ，Postoperative day 3
Incidence of Postoperative Adverse Events
大体时间：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.
Postoperative Day 1 - Day7

其他结果措施

结果测量
措施说明
大体时间
Serum IL-6 and Cortisol Concentrations
大体时间：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.
End of surgery, Postoperative Day1, Postoperative Day2
Serum Motilin and Gastrin Concentrations
大体时间：End of surgery, Postoperative Day1, Postoperative Day2
Detect serum motilin and gastrin to explore the effect of analgesic regimens on gastrointestinal endocrine function.
End of surgery, Postoperative Day1, Postoperative Day2
Plasma β-Endorphin Concentration
大体时间：End of surgery, Postoperative Day1, Postoperative Day2
Determine plasma β-endorphin level to explore central pain modulation mechanism of multimodal analgesia.
End of surgery, Postoperative Day1, Postoperative Day2

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tianjin First Central Hospital

调查人员

  • 研究主任：Wenli Yu、Tianjin First Central Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月16日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • TJH-2026-99

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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