Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
研究概览
简要总结
With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine in thyroidectomy, as preemptive analgesia.
The hypothesis was bupivacaine with the addition of clonidine would help in reducing postoperative pain and thereby reduce the need for postoperative analgesia.
详细描述
To find out if addition of BSCPB to general anesthesia with bupivacaine with or without clonidine prolongs the time needed for postoperative analgesic and facilitate to perform thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea and vomiting.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting consecutive euthyroid patients undergoing elective thyroidectomy under general anesthesia, of either genders and more than 18 years of age, belonging to the ASA class I and II.
排除标准
- •Patients unable to understand visual analog pain score (VAS) or unable to use patient controlled analgesia (PCA).
- •Patients with malignancy requiring block dissection or with substernal goiters - Contraindications to superficial cervical plexus block like allergy to local anesthetics, bleeding diatheses and local infection or sepsis.
- •Contraindications to morphine like bronchial asthma and hypothyroidism.
- •Sensitivity to the anesthetic agent used or intolerance to the medications used in the study.
- •Patients who received steroids or opioids or other analgesics recently.
- •Patients with history of stridor.
研究组 & 干预措施
Saline
0.9% normal saline
干预措施: 0.9% Normal saline (Drug)
Bupivacaine
0.25% bupivacaine
干预措施: Bupivacaine (Drug)
Bupivacaine with clonidine
0.25% bupivacaine with 1 microgram/kg of clonidine
干预措施: Bupivacaine with clonidine (combination) (Device)
结局指标
主要结局
Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
时间窗: Intraoperative to 24 hours postoperative
次要结局
- Visual analog pain scores at specific time intervals(24 hours postoperative)
- Postoperative nausea and vomiting (PONV)and anti emetic requirements(24 hours postoperative)
- Side effects of the block, morphine and clonidine(24 hours postoperative)
研究者
Karthikeyan V S
Senior Resident, Urology
Jawaharlal Institute of Postgraduate Medical Education & Research