Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy
Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial
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.
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Pondicherry、印度、605013
- Jawaharlal Institute Of Postgraduate Medical Education And Research
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Saline
0.9% normal saline
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Saline
其他名称：
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实验性的：Bupivacaine
0.25% bupivacaine
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Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
其他名称：
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实验性的：Bupivacaine with clonidine
0.25% bupivacaine with 1 microgram/kg of clonidine
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Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours Clonidine - 0.5 - 1 microgram/ kg
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period
大体时间：Intraoperative to 24 hours postoperative
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Intraoperative to 24 hours postoperative
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Visual analog pain scores at specific time intervals
大体时间：24 hours postoperative
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24 hours postoperative
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Postoperative nausea and vomiting (PONV)and anti emetic requirements
大体时间：24 hours postoperative
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24 hours postoperative
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Side effects of the block, morphine and clonidine
大体时间：24 hours postoperative
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24 hours postoperative
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合作者和调查者
调查人员
- 学习椅：Sarath Chandra Sistla, MS(Surgery)、Professor, Dept. of Surgery, JIPMER
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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