Effects of Ultrasound-Guided Intermediate Cervical Plexus Block on Postoperative Analgesia and Opioid Consumption in Vagus Nerve Stimulation Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Total postoperative morphine consumption during the first 24 hours after surgery
研究概览
简要总结
This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the analgesic efficacy of ultrasound-guided intermediate cervical plexus block (ICB) in patients undergoing vagus nerve stimulation (VNS) implantation surgery under general anesthesia. Participants are randomly assigned to receive either an ultrasound-guided ICB with 10 mL of 0.25% bupivacaine or a placebo injection with 10 mL of normal saline following induction of general anesthesia. The primary outcome is total postoperative morphine consumption during the first 24 hours after surgery. Secondary outcomes include intraoperative remifentanil consumption, postoperative pain intensity assessed using the Numeric Rating Scale (NRS), time to first analgesic request, length of hospital stay, and postoperative seizure incidence.
详细描述
Postoperative pain following vagus nerve stimulation (VNS) implantation surgery originates from both cervical and infraclavicular surgical incisions. Although opioid analgesics are commonly used for postoperative pain control, minimizing opioid exposure is particularly desirable in patients with drug-resistant epilepsy because opioid-related adverse effects may delay recovery and potentially influence neurological assessment.
The intermediate cervical plexus block (ICB) is an ultrasound-guided regional anesthesia technique that provides sensory blockade of the superficial branches of the cervical plexus while allowing accurate deposition of local anesthetic between the investing and prevertebral layers of the deep cervical fascia. Previous studies have demonstrated the effectiveness of cervical plexus blocks in various cervical surgical procedures; however, evidence regarding their use during VNS implantation surgery remains limited.
This prospective, randomized, double-blind, placebo-controlled study compares ultrasound-guided ICB using 10 mL of 0.25% bupivacaine with a placebo injection of 10 mL normal saline administered after induction of general anesthesia. The primary objective is to determine whether ICB reduces postoperative opioid requirements during the first 24 hours after surgery. Secondary objectives include evaluation of intraoperative remifentanil consumption, postoperative pain scores, time to first rescue analgesic, length of hospital stay, and postoperative seizure incidence. The findings are expected to provide evidence regarding the effectiveness and safety of ultrasound-guided intermediate cervical plexus block as part of multimodal analgesia for patients undergoing VNS implantation surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, postoperative care providers, and outcome assessors were blinded to treatment allocation. Study solutions were prepared in identical syringes by an independent anesthesiologist not involved in postoperative assessments or data analysis. The anesthesiologist performing the block was aware of the assigned intervention but did not participate in postoperative outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years
- •American Society of Anesthesiologists (ASA) physical status II-III
- •Drug-resistant epilepsy
- •Scheduled for elective vagus nerve stimulation implantation surgery under general anesthesia
- •Written informed consent obtained
排除标准
- •Allergy or contraindication to local anesthetics
- •Coagulopathy or current anticoagulant therapy
- •Infection at the injection site
- •Pregnancy or breastfeeding
- •Severe pulmonary disease
- •Inability to understand or use the Numeric Rating Scale (NRS)
- •Refusal to participate
结局指标
主要结局
Total postoperative morphine consumption during the first 24 hours after surgery
时间窗: 24 hours after surgery
Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
次要结局
- Intraoperative remifentanil consumption(From induction of anesthesia until the end of surgery)
- Postoperative pain intensity(From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively)
- Time to first rescue analgesic request(Within 24 hours after surgery)
- Length of hospital stay(From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively)
- Postoperative seizure incidence(Within 24 hours after surgery)
研究者
AHMET AKSU
Assistant Professor
Firat University