Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Morphine requirement post surgery
研究概览
简要总结
The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
详细描述
This study will be a prospective randomized single-blinded clinical trial.
Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate.
Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group
The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Patients undergoing shoulder arthroscopy
- •Patients willing to participate and sign informed consent
排除标准
- •Severe COPD/other contraindication to general anesthesia
- •Patient with a weight of less than 60 kg
- •Dementia, not alert or oriented to person, place, or time
- •Chronic pain patient with daily opioid use at home.
- •Patient with allergy to local anesthetics
- •Patient refusal
- •Total shoulder arthroplasty
- •Concomitant pain in different area from operative site.
- •Pregnancy
- •Patient with active infection on the injection sites for the blocks
- •Patients unable or willing to understand or comply with the study protocol
研究组 & 干预措施
Interscalene block with the addition of buprenorphine, clonidine, dexamethasone
Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane, 30mL of 0.5% bupivacaine with 100 mcg clonidine, 0.3 mg buprenorphine, and 4 mg dexamethasone will be injected.
干预措施: Interscalene block with the addition of buprenorphine, clonidine, dexamethasone (Drug)
Interscalene block with buprenorphine alone
Interscalene brachial plexus blocks (ISB) is performed with a 22g x 50 mm PAJUNK SonoPlexⓇ II Facet S echogenic needle. Once adequate needle visualization is achieved within the correct anatomic position and plane 30mL of 0.5% bupivacaine will be injected.
干预措施: Interscalene block with buprenorphine alone (Drug)
结局指标
主要结局
Morphine requirement post surgery
时间窗: 24 hours
To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups.
次要结局
- Pain reported via a numeric rating scale (NRS)(48 hours)
研究者
Audrice Francois, MD, FASA
Professor
Loyola University