Comparison of Single-Injection and Multiple-Injection Intertransverse Process Block for Postoperative Analgesia in Breast Cancer Surgery: A 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
- 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 single Intertransverse Process Block (ITP) and multiple Intertransverse Process Block (ITP) in patients undergoing Breast Cancer Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.
详细描述
Study Objective This study aims to compare the effectiveness of single-level and multilevel intertransverse process (ITP) block techniques for the management of acute postoperative pain in patients undergoing breast cancer surgery.
The primary objective of this study is to compare the effects of single-level and multilevel intertransverse process (ITP) block techniques on postoperative Visual Analog Scale (VAS) pain scores in patients undergoing breast cancer surgery. Secondary outcomes include comparing total opioid consumption within the first 24 hours after surgery and postoperative quality of recovery between the two techniques.
Materials and Methods: This prospective, randomized clinical study will include voluntary female 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 Patients who meet the exclusion criteria will be withdrawn from the study.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: In the single-level ITP group, the block will be performed unilaterally at the T4-T5 intertransverse level with a single injection. In the multilevel ITP group, the block will be performed unilaterally at four intertransverse levels (T2-T3, T3-T4, T4-T5, and T5-T6).
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.
Single-Level 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years
- •ASA physical status I-III
- •Scheduled for elective breast cancer surgery
- •Body mass index (BMI) between 18 and 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) <18 or >35 kg/m²
研究组 & 干预措施
Single Level Intertransverse Process Block
干预措施: Single Level Intertransverse Process Block (Procedure)
Multiple Level Intertransverse Process Block
干预措施: Multiple Level Intertransverse Process Block (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. Measurements will be recorded at predefined time points within the first 24 hours after surgery.
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)
- Block performance time(During the block procedure)
- Block-related and systemic side effects(Within the first 24 hours postoperatively)
- Patient and Surgeon satisfaction assessed using a Likert scale(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 anesthesiology
Antalya City Hospital