A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
详细描述
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have or are:
- •Orthopedics service patients having shoulder surgery
- •ASA(American Society of Anesthesiologists) class I, II, or III.
- •Patients at least 18 years old but less than 71 years old.
- •Patients giving informed consent.
- •Non-Emergency Surgery
排除标准
- •Patients who have or are:
- •An inability to cooperate during the block placement.
- •Neuropathy of the planned extremity to block
- •Documented Kidney Disease
- •Documented Liver Disease
- •A lack of or inability to give informed consent.
- •Currently incarcerated.
研究组 & 干预措施
Plain Ropivacaine
Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
干预措施: Ropivacaine 0.75% (Drug)
Ropivacaine + Buprenorphine
A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
干预措施: Ropivacaine 0.75% + 300 mcg Buprenorphine (Drug)
Ropivacaine + Clonidine
A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
干预措施: Ropivacaine 0.75% + 75 mcg clonidine (Drug)
Ropivaciane + Dexamethasone
A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
干预措施: Ropivacaine 0.75% + 8 mg dexamethasone (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: 1-3 days post-operative
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
次要结局
- Number of Patients Reporting Itching at Home(1-3 days)
- Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area(Post-op Day 0 (baseline))
- Sensory Duration of Block(Day 1-3)
- Number of Patients Reporting Nausea in the PACU(Post-op day 0 (Baseline))
- Motor Duration of Block(Day 1-3)
- Block Set up Time(Day one)
- Patient Reporting Vomiting at Home(1-3 days)
- Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)(Post-op Day 0 (Baseline))
- Number of Patients Reporting Nausea at Home(1-3 days)
- Pain Score Reported by Patients at First Phone Call(Day 1-3)
- Number of Patients With Blood Pressure (BP) Changes in the PACU(Post-op Day 0 (baseline))
- Number of Patients Reporting Itching in the PACU(Post-op day 0 (baseline))
研究者
Melinda Seering
Clinical Assistant Profession, Prinicipal Investigator
University of Iowa
