Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Controlled Trial
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 pain intensity (VAS score)
研究概览
简要总结
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block-related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
详细描述
Study Objective: This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Intertransverse Process Block (ITPB) and Subcostal Transversus Abdominis Plane Block (TAPB) on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic sleeve gastrectomy. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours, requirement for rescue analgesia, block-related and systemic complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Materials and Methods: This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) >35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.
Study Groups and Block Procedures: Group ITP will receive a bilateral ITP block, and Group TAPB will receive a bilateral subcostal TAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.
ITP Block :
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)
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
- •Patients aged 18-65 years
- •ASA physical status I-III
- •Scheduled for elective laparoscopic sleeve gastrectomy
- •Body mass index (BMI) >35 kg/m²
- •Ability to understand and use the patient-controlled analgesia (PCA) device
- •Ability to provide written informed consent
排除标准
- •Refusal to participate
- •Allergy to local anesthetics
- •Infection at the injection site
- •Coagulopathy or ongoing anticoagulant therapy
- •Chronic opioid use or opioid dependence
- •Severe hepatic or renal insufficiency
- •Pregnancy or breastfeeding
- •Cognitive impairment or inability to communicate pain scores
- •Body mass index (BMI) >35 kg/m²
研究组 & 干预措施
Intertransverse Process Block (ITPB)
干预措施: Intertransverse Process Block (Procedure)
Subcostal Transversus Abdominis Plane Block (TAPB)
干预措施: The Subcostal Transversus Abdominis Plane Block (TAPB) (Procedure)
结局指标
主要结局
Postoperative pain intensity (VAS score)
时间窗: 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
次要结局
- Total opioid consumption via patient-controlled analgesia (PCA)(Within the first 24 hours postoperatively)
- Requirement for rescue analgesia(Within the first 24 hours postoperatively)
- Potential Complications(Within the first 24 hours postoperatively)
- Patient satisfaction(At 24 hours postoperatively)
- Quality of recovery assessed using the QoR-15 questionnaire(At 24 hours postoperatively)
- İncedence of postoperative nausea and vomiting(Within the first 24 hours postoperatively)
研究者
Mustafa Kılın
consultant in anesthesiology
Antalya City Hospital