Preoperative TAP Block Versus Postoperative TAP Block in Patients Undergoing Laparoscopic Cholecystectomy: 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
- 46
- 试验地点
- 1
- 主要终点
- Patient reported pain on movement at 24 hours after the surgery
研究概览
简要总结
The goal of this clinical trial is to learn if the regional anesthesia technique "TAP block" provide more analgesia when performed before or after the surgery. The main questions it aims to answer are:
Does preoperative TAP block provide greater analgesia than postoperative TAP block? Patients receiving preoperative TAP block will have less pain and take less painkillers than patients receiving postoperative TAP block?
Participants will:
Receive preoperative or postoperative TAP block They will be asked about their pain levels during the hospital stay.
详细描述
The TAP block is a safe, easy-to-perform, and effective technique for managing postoperative pain. It reduces opioid consumption and increases patient satisfaction. Despite recent studies indicating that postoperative TAP block might be more effective than preoperative TAP block in reducing opioid use within 24 hours, the optimal timing of its administration (before or after surgery) remains unclear.
In this study we will compare preoperative to postoperative TAP block in patients undergoing laparoscopic cholecistectomy.
The primary aim of this study is to determine the difference in postoperative pain control between preoperative and postoperative TAP block administration in patients undergoing laparoscopic cholecystectomy.
The primary objective will be to evaluate the difference in postoperative pain at rest, 24 hours after surgery, between patients receiving preoperative versus postoperative TAP block. Pain will be assessed using the Numeric Rating Scale (NRS) from 0 to 10.
Secondary objectives will be intraoperative and postoperative opioids, postoperative nausea and vomiting, pain at resnt and on movement at 0,6,12,24 hours.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant will be masked as the intervention (TAP block) will be performed after induction of general anesthesia Outcome assessor will be unaware of the group assignment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients
- •Age >18 years
- •Informed consent
排除标准
- •History of chronic pain
- •Beta-blocker therapy
- •Allergy to the drugs used in the study
研究组 & 干预措施
Preoperative TAP block
Patients will receive a preoperative TAP block with 40 mL (20 mL on the right side + 20 mL on the left side) of Ropivacaine 0.4%
干预措施: Preoperative TAP Block (Procedure)
Postoperative TAP block
Patients will receive a postoperative TAP block with 40 mL (20 mL on the right side + 20 mL on the left side) of Ropivacaine 0.4%
干预措施: Postoperative TAP block (Procedure)
结局指标
主要结局
Patient reported pain on movement at 24 hours after the surgery
时间窗: At the 24th hour after the end of the surgery.
Pain will be assessed with the 11 points NRS scale (0-10)
次要结局
- Number of participants experiencing postoperative nausea and vomiting(From extubation to the 24th postoperative hour)
- Patient reported pain on movement (cough) at the end of the surgery(At the end of the surgery.)
- Patient reported pain on rest at the end of the surgery(At the end of the surgery.)
- Patient reported pain on rest at 6 hours after the surgery(At the 6th hour after the end of the surgery.)
- Patient reported pain on movement at 6 hours after the surgery(At the 6th hour after the end of the surgery.)
- Patient reported pain on rest at 12 hours after the surgery(At the 12th hour after the end of the surgery.)
- Patient reported pain on movement at 12 hours after the surgery(At the 12th hour after the end of the surgery.)
- Patient reported pain on rest at 24 hours after the surgery(At the 24th hour after the end of the surgery.)
- Difference in intraoperative opioids(From the enrollment to the extubation)
- Difference in postoperative opioids(From the extubation to the 24th postoperative hours)
研究者
Alessandro De Cassai
Medical Doctor
University of Padova