Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Quality of recovery
研究概览
简要总结
Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.
详细描述
Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.
Several strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.
Ultrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.
Owing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.
Quality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.
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
- Single (Outcomes Assessor)
盲法说明
All blocks will be performed by the same anesthesiologist while the measurements will be recorded by anesthesiologist who has no idea about patient allocation.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 to 65 years
- •American Society of Anesthesiologists physical status I or II.
- •Scheduled for elective thyroid surgery.
排除标准
- •Patient refusal to participate.
- •Patients with history of allergy to local anesthetics.
- •Patients with history of chronic use of pain killers .
- •Patients presented with mental dysfunction.
- •Patients with coagulation disorders.
- •Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
- •Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.
研究组 & 干预措施
Sham Technique
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.
干预措施: Ultrasound-guided Bilateral superficial cervical plexus block (Procedure)
Sham Technique
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.
干预措施: Midazolam (Drug)
Ultrasound-guided Bilateral superficial cervical plexus block
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).
干预措施: Ultrasound-guided Bilateral superficial cervical plexus block (Procedure)
Ultrasound-guided Bilateral superficial cervical plexus block
Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).
干预措施: Midazolam (Drug)
结局指标
主要结局
Quality of recovery
时间窗: 24 hours postoperatively.
Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed . Each item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).
次要结局
- Postoperative analgesia(24 hours postoperatively)
- Opioid consumption(24 hours postoperatively)
- Diaphragmatic Excursion(24 hours postoperatively)