Effect of Transversus Abdominis Plane (TAP) Block on Postoperative Gastrointestinal Function After Laparoscopic Sleeve Gastrectomy: Evaluation Using the PRO-diGI Scale and Perlas Score (Prospective Clinical Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Gastrointestinal Function
研究概览
简要总结
This prospective clinical study aims to evaluate the effect of Transversus Abdominis Plane (TAP) block on postoperative gastrointestinal function in patients undergoing laparoscopic sleeve gastrectomy. Gastrointestinal recovery plays a crucial role in patient outcomes after bariatric surgery, and regional anesthesia techniques such as TAP block have been suggested to reduce postoperative pain and opioid consumption, which may influence gut motility.
In this study, postoperative gastrointestinal function will be assessed using the validated Patient-Reported Outcome for Dysfunctional Gastrointestinal Motility (PRO-diGI) scale. Additionally, gastric ultrasound will be performed to calculate the Perlas score as an objective marker of gastric emptying and residual volume. These assessments will allow a comprehensive evaluation of both subjective and objective gastrointestinal recovery parameters.
The study will include adult patients scheduled for elective laparoscopic sleeve gastrectomy at Elazığ Fethi Sekin City Hospital. Participants will receive standard general anesthesia with or without ultrasound-guided TAP block, and their postoperative recovery will be monitored. Primary outcomes include PRO-diGI scores at defined postoperative intervals, while secondary outcomes include Perlas scores obtained via gastric ultrasonography.
The findings from this research are expected to provide valuable insights into the potential benefits of TAP block on gastrointestinal motility and overall recovery after bariatric surgery.
详细描述
Bariatric surgery, particularly laparoscopic sleeve gastrectomy, is an effective intervention for morbid obesity. However, postoperative gastrointestinal dysfunction, including delayed gastric emptying and impaired gut motility, can adversely impact recovery, prolong hospital stay, and reduce patient satisfaction. Factors such as opioid-based analgesia are known contributors to postoperative ileus and gastrointestinal dysmotility. Therefore, optimizing pain management strategies while minimizing opioid use is critical for enhanced recovery.
The Transversus Abdominis Plane (TAP) block is a regional anesthesia technique that provides effective abdominal wall analgesia, reducing opioid consumption and associated adverse effects. While its role in postoperative pain control is well established, limited evidence exists regarding its impact on gastrointestinal function, particularly in the context of bariatric surgery.
Study Objective:
The primary objective of this study is to evaluate whether the application of ultrasound-guided TAP block affects postoperative gastrointestinal function after laparoscopic sleeve gastrectomy. Gastrointestinal recovery will be assessed using the PRO-diGI scale, which captures patient-reported symptoms of gastrointestinal motility, and the Perlas gastric ultrasound score, which provides an objective estimate of gastric content and residual volume.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 years
- •Scheduled for primary laparoscopic sleeve gastrectomy (LSG)
- •Body Mass Index (BMI) ≥ 35 kg/m²
- •ASA Physical Status II-III
- •Ability to provide written informed consent
排除标准
- •Previous major abdominal surgery
- •Known allergy to local anesthetics
- •Severe hepatic or renal dysfunction
- •Pregnancy or breastfeeding
- •Conversion to open surgery during the procedure
- •Patients refusing TAP block or general anesthesia
结局指标
主要结局
Postoperative Gastrointestinal Function
时间窗: Postoperative 6, 12, 24, and 48 hours
Description: Assessed using the validated Patient-Reported Outcome for Dysfunction in Gastrointestinal Recovery after Surgery (PRO-diGI) scale, which captures patient-reported symptoms of gastrointestinal motility, including nausea, vomiting, bloating, and oral intake tolerance. The scale ranges from 0 to 15, with higher scores indicating greater gastrointestinal dysfunction and worse postoperative GI function.
次要结局
- Perlas Score(Preoperative and immediate postoperative period)
- Opioid Consumption(First 48 hours postoperatively)
- Pain Scores (NRS)(2, 6, 12, 24, and 48 hours postoperatively)
- Adverse Events(From immediately after surgery up to 7 days postoperatively)