Comparison of Superficial Cervical Plexus Block and Ketamine in the Prevention of Chronic Pain After Thyroidectomy: Results of a Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- The incidence of chronic neuropathic pain at three months
研究概览
简要总结
The goal of our work is to to compare the effect of preemptive Ketamine administration versus superficial cervical plexus block on the incidence of postoperative neuropathic pain in patients undergoing thyroidectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years
- •Scheduled for thyroidectomy under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to understand the study procedures and provide written informed consent
排除标准
- •Known allergy to ketamine or local anesthetics
- •Severe renal impairment with estimated Glomerular Filtration Rate (eGFR) under 30 mL/min
- •History of neurological disorders
- •History of psychiatric illness
- •History of severe cardiac disease (NYHA III-IV) or serious arrhythmias
- •Pregnancy or breastfeeding
- •Morbid obesity (BMI > 40 kg/m²)
- •Cognitive or communication impairment
- •Refusal to participate
研究组 & 干预措施
BCS Group
Patients received a bilateral ultrasound-guided superficial cervical plexus block after induction (Ropivacaine 0.2%,with a volume of 10 mL administered to each side)
干预措施: Superficial cervical plexus block (Procedure)
KETA group
Patients received intravenous ketamine (0.25 mg/kg bolus followed by a 2 µg/kg/min infusion).
干预措施: Ketamine perfusion (Drug)
结局指标
主要结局
The incidence of chronic neuropathic pain at three months
时间窗: three months after thyroidectomy
The incidence of chronic neuropathic pain at three months after thyroidectomy, as determined by the DN4 questionnaire.
次要结局
- Twenty-four hour postoperative rescue analgesia requirements(within the first 24 hours after the thyroidectomy.)
- Intraoperative sufentanil consumption(During the intraoperative period)
- Postoperative sleep quality(During the first 24 postoperative hours.)
- Incidence of postoperative nausea and vomiting (PONV) within 24 hours post-surgery(24 hours after surgery.)
- The Observer's Assessment of Alertness/Sedation (OAA/S) within a 2-hour timeframe following thyroidectomy.(2-hour timeframe following thyroidectomy)
研究者
Ben Taleb Ibtissem
Assistant Professor in Anesthesiology and Intensive Care
University Tunis El Manar