Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia
Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
研究概览
地位
条件
详细说明
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Istanbul、土耳其(türkiye)
- Istanbul Medipol University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Exclusion Criteria:
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
- Presence of neurological disease.
- Refusal to participate in the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途: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:Group QLB
Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
实验性的:Group TFP
Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery.
|
Bilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL).
Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
|
|
有源比较器:Group Control
Patients will receive only port site infiltration at the end of the surgery.
|
Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.
|
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 |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Score
大体时间:At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain".
Higher scores represent worse pain outcomes.
|
At 0, 3, 6, 12, 18, and 24 hours postoperatively.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Tramadol Consumption
大体时间:During the first 24 hours postoperatively.
|
The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.
|
During the first 24 hours postoperatively.
|
|
Need for Rescue Analgesia
大体时间:During the first 24 hours postoperatively
|
The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.
|
During the first 24 hours postoperatively
|
|
Incidence of Opioid-Related Side Effects
大体时间:During the first 24 hours postoperatively.
|
The number of patients experiencing postoperative nausea, vomiting, or sedation.
|
During the first 24 hours postoperatively.
|
|
Incidence of Block-Related Complications
大体时间:During the first 24 hours postoperatively.
|
The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).
|
During the first 24 hours postoperatively.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
- İnguinal QLB vs TFP
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.