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临床试验/NCT03117140
NCT03117140已完成4 期

A Prospective Triple-masked Randomized Controlled Trial Measuring Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

Melinda Seering1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Experimental

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

Experimental

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

Experimental

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

发起方
Melinda Seering
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melinda Seering

Clinical Assistant Profession, Prinicipal Investigator

University of Iowa

研究点 (1)

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