The Effect of Dexamethasone Adjuvant to Varying Doses of Bupivacaine on Motor and Sensory Blockade in Infraclavicular Brachial Plexus Blockade
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration of motor and sensory block
研究概览
简要总结
This single-center, prospective, randomized, double-blinded controlled trial investigates the effects of adding 4 mg dexamethasone to different concentrations of bupivacaine on motor and sensory block duration in infraclavicular brachial plexus block. A total of 120 ASA I-II patients aged 18-65 undergoing elective surgeries of the hand, wrist, forearm, or elbow will be randomly assigned to one of four groups:
Group 1: 25 mL of 0.5% bupivacaine. Group 2: 25 mL of 0.5% bupivacaine with 4 mg dexamethasone. Group 3: 25 mL of 0.375% bupivacaine with 4 mg dexamethasone. Group 4: 25 mL of 0.25% bupivacaine with 4 mg dexamethasone. The infraclavicular block will be performed using a lateral sagittal approach under ultrasound and nerve stimulator guidance. Primary outcomes include the duration of motor and sensory block, assessed with a motor block scale and pin-prick sensory test. Secondary outcomes include block onset times, postoperative pain scores (Visual Analog Scale), total analgesic consumption within 48 hours, time to first postoperative analgesic, and rates of rescue block or conversion to general anesthesia.
This study aims to evaluate whether combining dexamethasone with lower concentrations of bupivacaine can maintain block efficacy while reducing local anesthetic dosage, potentially improving the safety and effectiveness of peripheral nerve block protocols.
详细描述
This study investigates whether adding dexamethasone, a commonly used steroid, to different strengths of bupivacaine (a local anesthetic) can improve the effectiveness and duration of nerve blocks used for upper limb surgeries. The nerve block in this study is an infraclavicular brachial plexus block, which numbs the arm and hand by targeting specific nerves near the shoulder. This type of anesthesia is often preferred for surgeries of the hand, wrist, forearm, or elbow because it reduces pain and the need for general anesthesia.
What Is Being Studied? The research focuses on four groups of patients receiving different mixtures of bupivacaine, with or without dexamethasone. Each patient will receive the same volume of anesthetic solution (25 mL) through a standardized procedure performed under ultrasound and nerve stimulator guidance.
- Group 1: 0.5% bupivacaine only.
- Group 2: 0.5% bupivacaine with 4 mg dexamethasone.
- Group 3: 0.375% bupivacaine with 4 mg dexamethasone.
- Group 4: 0.25% bupivacaine with 4 mg dexamethasone. Why Is This Important? Local anesthetics like bupivacaine can effectively block pain, but using higher concentrations may carry risks, such as muscle weakness or local anesthetic toxicity. Combining dexamethasone with lower concentrations of bupivacaine might extend the block's duration and effectiveness, potentially reducing the total amount of anesthetic needed. This could improve patient safety and recovery while maintaining excellent pain control.
How Will It Be Done? The study involves 120 adult patients aged 18-65, all undergoing elective upper limb surgeries. Participants will be randomly assigned to one of the four groups, and both the patients and the doctors evaluating their progress will not know which group they are in.
Before surgery, each patient will receive the nerve block. The anesthetic solution will be injected near the shoulder, targeting specific nerves with the help of ultrasound and a nerve stimulator. Researchers will measure:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years with ASA I-II who will undergo surgery on the hand, wrist, forearm, or elbow.
排除标准
- •Patient refusal to undergo the procedure
- •ASA III or higher status
- •Diagnosis of diabetes mellitus
- •Pregnancy
- •History of multiple trauma
- •Patients with communication difficulties during or after the procedure
- •Sensory impairment at the site of regional anesthesia application
- •Presence of a neuromuscular disease
- •Open wound or infection at the site of block application
- •Coagulopathy that contraindicates the block
- •History of allergy to the drugs to be used
研究组 & 干预措施
Group 1: 0.5% bupivacaine only
Group 1: 25 ml of 0.5% bupivacaine for infraclavicular brachial plexus block
干预措施: Infraclavicular Brachial Plexus Blocks (Procedure)
Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone
"Group 3: 25 ml of 0.375% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block.
干预措施: Infraclavicular Brachial Plexus Blocks (Procedure)
Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution
Group 4: 25 ml of 0.25% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block.
干预措施: Infraclavicular Brachial Plexus Blocks (Procedure)
Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone
Group 2: 25 ml of 0.5% Bupivacaine and 4 mg Dexamethasone-containing local anesthetic solution for infraclavicular brachial plexus block
干预措施: Infraclavicular Brachial Plexus Blocks (Procedure)
结局指标
主要结局
Duration of motor and sensory block
时间窗: 48 hours
The primary outcome of this study is to examine the effects of different concentrations of bupivacaine combined with dexamethasone, in the same volume, on the duration of motor block and sensory block during infraclavicular brachial plexus block.
次要结局
- Block Onset Time(30 minutes)
- Postoperative pain levels(48 hours)
- Total analgesic requirements(48 hours)
- Block Failure(30 minutes)
研究者
Döndü Genc Moralar
Assoc. Prof.
Gaziosmanpasa Research and Education Hospital