Dexmedetomidine as an Adjuvant to Local Anesthesia in Supraclavicular Plexus Block, A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The onset of anaesthesia in supraclavicular plexus block
研究概览
简要总结
In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.
详细描述
Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.
Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).
On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.
Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.
Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-75 years.
- •Classified as grades 1 or 2 by the American Society of Anesthesiology Classification of .physical status.
- •Willing and able to sign a consent form.
排除标准
- •Patients under the following conditions will be excluded: Known hypersensitivity to Bupivacaine, Dexmedetomidine, and local anesthetics.
- •Uncontrolled diabetes mellitus.
- •Peripheral neuropathy.
- •SevereCoagulopathy.
- •Infection at the site of block.
- •Pregnancy.
- •Cardiac arrhythmias.
- •Prescription of beta blockers.
- •Psychological disorders.
研究组 & 干预措施
Dexmedetomidine and Bupivacaine
Patients will be given Dexemtomidine ( the intervention) added to the Bupivacaine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The onset of anaesthesia in supraclavicular plexus block
时间窗: "up to 9 hours"
Sensory block assessed by pinprick test with a blunt 25-G hypodermic needle. Grade 0: sharp pin sensation felt, grade 1: analgesia, dull sensation felt, grade 2: anesthesia, no sensation felt the onset of sensory block is the interval between the end of total local anesthetic administration and sensory block grade 1
The duration of anesthesia in supraclavicular plexus block
时间窗: "up to 9 hours"
The motor blockade assessed using the Modified Bromage scale (MBS). Grade 0: able to raise the extended arm to 90 degrees for 2 seconds; grade 1: able to bend the elbow and move the fingers but not the extended arm; grade 2: unable to flex the elbow but able to move the fingers; grade 3: unable to move the arm, elbow, and fingers. The onset of the motor blockade is the interval from injection of the local anesthetic to motor analysis equivalent to Bromage score 2
次要结局
- Intraoperative heart rate("1 hour")
- Intraoperative blood pressure as mm Hg("1 hour")
- Intraoperative somnolence("1 hour")
- Post-operative blood pressure("up to 6 hours")
- Post-operative heart rate("up to 6 hours")
- Post-operative somnolence("up to 6 hours")
- Number of Participants With Postoperative nausea and vomiting.("up to 6 hours")
研究者
Zaher Nazzal
Head of Research Unit
An-Najah National University