Comparison of Perioperative Analgesia Nociception Index (ANI) Between Preoperative and Postoperative Ultrasound-guided Transversus Abdominis Plane Block(TAP Block) in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Intraoperative Analgesia Nociception Index (ANI)
研究概览
简要总结
The goal of this clinical trial is to learn if the timing of ultrasound-guided transversus abdominis plane block (US-TAP block) administration (preoperative vs. postoperative) affects the perioperative analgesia nociception index (ANI) in adult patients undergoing laparoscopic cholecystectomy. The main questions it aims to answer are:
- Does the timing of the US-TAP block significantly influence intraoperative ANI values?
- Does the difference in US-TAP block timing and subsequent ANI values correlate with actual patient recovery, postoperative pain scores (VAS), and complication rates?
If there is a comparison group: Researchers will compare the experimental group (Group A: US-TAP block before surgical incision) to the control group (Group B: US-TAP block after wound closure) to see if early block administration provides superior intraoperative pain suppression and reduces postoperative pain or analgesic consumption.
Participants will:
- Undergo standard general anesthesia induction and maintenance.
- Receive a bilateral US-TAP block with a total of 30 mL of 0.2% ropivacaine, administered either before incision (Group A) or after closure (Group B).
- Be monitored via standard monitoring devices alongside an ANI monitor.
- Use an intravenous patient-controlled analgesia (IV-PCA) pump for 24 hours after surgery.
- Participate in postoperative assessments to measure pain scores (VAS), rescue analgesic consumption, satisfaction, and complications at specific intervals up to 24 hours post-surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo laparoscopic cholecystectomy.
- •Aged 19 years or older.
- •American Society of Anesthesiologists (ASA) physical status I, II, or III.
排除标准
- •Patients who lack the capacity to understand the study examinations or perform the assessment procedures.
- •Patients with coagulation deficiencies or bleeding disorders.
- •Patients with cardiac arrhythmias or those with an implanted cardiac pacemaker.
- •Patients taking medications that affect the autonomic nervous system, including beta-blockers and opioid analgesics.
- •Patients with surgical scars, active lesions, or anatomical abnormalities at the block site.
- •Patients with pre-existing neurological deficits or impairment at the block site.
- •Patients with a known history of allergic reactions or hypersensitivity to ropivacaine or other local anesthetics.
- •Pregnant or lactating individuals.
研究组 & 干预措施
Group A: Preoperative US-TAP Block
Patients receiving ultrasound-guided transversus abdominis plane block immediately after general anesthesia induction, prior to surgical incision.
干预措施: Preoperative US-TAP Block (Procedure)
Group B: Postoperative US-TAP Block
Patients receiving ultrasound-guided transversus abdominis plane block after surgical wound closure is completed, before discontinuing inhalation anesthetics.
干预措施: Postoperative US-TAP Block (Procedure)
结局指标
主要结局
Intraoperative Analgesia Nociception Index (ANI)
时间窗: From anesthesia induction until the end of surgery (approximately 1-2 hours)
次要结局
- Postoperative Pain Intensity via Visual Analogue Scale (VAS)(Up to 24 hours post-surgery (Specifically measured at: upon arrival at the PACU, immediately before PACU discharge, and at 12 and 24 hours post-surgery))
- Cumulative Postoperative Rescue Analgesic Consumption(From the end of surgery up to 24 hours post-surgery)
- Incidence of Postoperative Complications and Adverse Events(From the end of surgery up to 24 hours post-surgery)
- Patient Satisfaction Score for Postoperative Pain Management(At 24 hours post-surgery)
研究者
Hyeon-soo Park
Assistant Professor, Department of Anesthesiology and Pain Medicine
Pusan National University Yangsan Hospital