The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative Pain Scores (NRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of the superficial cervical block in postoperative pain management for patients undergoing total laryngectomy and bilateral neck dissection. It will also assess its impact on recovery and clinical outcomes. The main questions it aims to answer are:
Does the superficial cervical block reduce postoperative pain scores? What are the effects of the block on ventilation status, ICU stay, and hospital length of stay? Researchers will compare patients who receive the superficial cervical block to those who do not, assessing its effectiveness in pain management and postoperative recovery.
Participants will:
Receive a superficial cervical block or standard pain management during surgery Have their pain levels assessed using the Numeric Rating Scale (NRS) at 30 min, 4, 8, and 24 hours postoperatively Have their postoperative ventilation status, ICU stay, hospital length of stay, and complications recorded
详细描述
Background and Rationale:
Total laryngectomy with bilateral neck dissection is a major head and neck surgery that significantly impacts postoperative recovery and pain management. Effective analgesia is crucial in these patients to facilitate early rehabilitation, optimize respiratory function, and improve overall outcomes. Conventional postoperative pain management strategies often rely on systemic opioids, which may lead to adverse effects such as respiratory depression, nausea, and sedation, potentially delaying recovery and increasing ICU length of stay.
The superficial cervical block (SCB) is a regional anesthesia technique that provides analgesia by targeting the superficial branches of the cervical plexus. It has been shown to reduce postoperative pain in head and neck surgeries while minimizing opioid-related side effects. However, its efficacy in patients undergoing total laryngectomy with bilateral neck dissection remains understudied. This study aims to evaluate whether the addition of a superficial cervical block to standard anesthesia protocols improves postoperative pain management and enhances recovery outcomes in these patients.
Study Objectives:
The primary objective of this study is to determine the effectiveness of the superficial cervical block in reducing postoperative pain in patients undergoing total laryngectomy and bilateral neck dissection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Postoperative pain assessments (NRS scores at 30 min, 4 h, 8 h, and 24 h), opioid consumption, and recovery outcomes will be recorded by an independent investigator who is unaware of the intervention status to reduce observer bias.
Data Analyst Masking:
The data will be analyzed by a statistician who is blinded to the group assignments to prevent bias in statistical interpretation.
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
- •Patients scheduled for total laryngectomy with bilateral neck dissection.
- •Age ≥18 years.
- •ASA (American Society of Anesthesiologists) classification I-IV.
- •Patients who provide written informed consent.
排除标准
- •Patients undergoing emergency surgery.
- •Patients with known allergies to local anesthetics (e.g., bupivacaine, lidocaine).
- •Patients with coagulopathy or bleeding disorders that contraindicate regional anesthesia.
- •Patients with severe cognitive impairment affecting informed consent.
- •Patients with infection at the injection site preventing SCB administration.
结局指标
主要结局
Postoperative Pain Scores (NRS)
时间窗: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively
Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points.
次要结局
- Postoperative Opioid Consumption(1 day)
- Cough Severity Score(30 minutes, 4 hours, 8 hours, and 24 hours postoperatively)
研究者
Hilal AKCA
M.D.
Başakşehir Çam & Sakura City Hospital