Laparoscopic-Assisted TAP Block VErsus Trocar-site Infiltration After Laparoscopic Appendectomy
Comparison of Laparoscopic-Assisted Transversus Abdominis Plane Block and Trocar-Site Local Anesthetic Infiltration After Laparoscopic Appendectomy: A Randomized Controlled Trial
This randomized controlled trial compared laparoscopic-assisted transversus abdominis plane (TAP) block with trocar-site local anesthetic infiltration for postoperative pain management in adult patients undergoing laparoscopic appendectomy for uncomplicated acute appendicitis. Sixty patients were randomized to receive either bilateral laparoscopic-assisted TAP block or local anesthetic infiltration at the trocar sites. Postoperative pain intensity, rescue analgesic requirements, recovery parameters, postoperative nausea and vomiting, complications, and length of hospital stay were evaluated.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Istanbul
-
Istanbul、Istanbul、土耳其(türkiye)
- Fatih Sultan Mehmet Training and Reserch Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-65 years
- ASA physical status I-II
- Uncomplicated acute appendicitis without perforation or phlegmon
- Undergoing laparoscopic appendectomy
- Written informed consent
Exclusion Criteria:
- Allergy to local anesthetics
- Systemic disease such as diabetes mellitus, chronic kidney failure, or bleeding diathesis
- Infection at the block application site
- Regular analgesic use for chronic pain
- Alcohol or narcotic dependence
- Intraoperative diagnosis of perforated or phlegmonous appendicitis
- Conversion from laparoscopic to open surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:laparoscopic-assisted TAP Block
Participants received a bilateral laparoscopic-assisted transversus abdominis plane (TAP) block after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. |
Bilateral laparoscopic-assisted transversus abdominis plane (TAP) block was performed after induction of general anesthesia. Under direct laparoscopic visualization, 15 mL of 0.25% bupivacaine was administered on each side, for a total volume of 30 mL and a total bupivacaine dose of 75 mg. |
|
有源比较器:trocar-site local anesthetic infiltration
Participants received local anesthetic infiltration at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg. |
Local anesthetic infiltration was performed at the three trocar sites before skin incision. A total of 15 mL of 0.5% bupivacaine was administered, with 5 mL infiltrated at each trocar site into the skin, subcutaneous tissue, and fascia, for a total bupivacaine dose of 75 mg. |
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 |
|---|---|---|
|
Postoperative Pain Intensity Assessed by Visual Analog Scale (VAS)
大体时间:Postoperative hours 0, 2, 6, 12, and 24
|
Postoperative pain at rest was assessed using the Visual Analog Scale (VAS) in both study groups at predefined postoperative time points. |
Postoperative hours 0, 2, 6, 12, and 24
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FSMEAH-TAP-207-26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified individual participant data underlying the results reported in this study and related analysis outputs will be available from the corresponding author upon reasonable request.
IPD 共享时间框架
Data will be available upon reasonable request following publication of the study results.
IPD 共享访问标准
De-identified individual participant data and related analysis outputs will be available to researchers upon reasonable request to the corresponding author.
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研究美国 FDA 监管的设备产品
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