Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Function in Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Control Group（Ropivacaine + Sufentanil）
TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
干预措施: Sufentanil citrate (Drug)
Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
干预措施: Liposomal bupivacaine (LB) (Drug)
Experimental Group 1（Liposomal Bupivacaine + Sufentanil）
TAP block with Liposomal Bupivacaine 266mg + PCIA Sufentanil for postoperative analgesia after abdominal surgery
干预措施: Sufentanil citrate (Drug)
Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
干预措施: Liposomal bupivacaine (LB) (Drug)
Experimental Group 2（Liposomal Bupivacaine + Oxycodone）
TAP block with Liposomal Bupivacaine 266mg + PCIA Oxycodone for postoperative analgesia after abdominal surgery
干预措施: oxycodone (Drug)
Control Group（Ropivacaine + Sufentanil）
TAP block with 0.375% Ropivacaine + PCIA Sufentanil for postoperative analgesia after abdominal surgery
干预措施: ropivacaine hydrochloride (Drug)
结局指标
主要结局
Area Under Curve (AUC) of I-FEED Score within Postoperative 7 Days
时间窗: 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.
次要结局
- 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.)
- First Ambulation Time & Length of Hospital Stay(LOS)(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(Postoperative day 1，Postoperative day 2 ，Postoperative day 3)
- Incidence of Postoperative Adverse Events(Postoperative Day 1 - Day7)
研究者
Wenli Yu
Chief Physician
Tianjin First Central Hospital