NCT00672100已完成不适用
The Effect Of Initial Local Anesthetic Dose With Continuous Interscalene Analgesia On Postoperative Pain And Diaphragmatic Function In Arthroscopic Shoulder Surgery Patients: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Diaphragmatic Displacement From Baseline to Post-surgery
研究概览
简要总结
Objective: To determine a minimally effective initial local anesthetic bolus required to provide satisfactory analgesia using continuous brachial plexus infusion following arthroscopic shoulder surgery using a double-blind, randomized, study comparing 3 initial doses.
详细描述
Aims:
- To compare pain ratings and supplemental analgesic requirements at discharge from PACU, 24 hours, and 48 hours and 12 weeks following 5, 10, and 20 ml boluses.
- To compare adverse events including clinical dysphonia, Horner's syndrome, dyspnea, unexpected hospitalization, evidence of local anesthetic toxicity, and hand weakness at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare impairment in diaphragmatic excursion at discharge from PACU following 5, 10, and 20 ml boluses.
- To compare patients' satisfaction with analgesia at 24 and 48 hours following 5, 10, and 20 ml boluses.
- To compare patient rating of functional outcome at baseline and at 12 weeks following 5, 10, and 20 ml boluses.
- To compare the rate of general anesthesia required following 5, 10, and 20 ml boluses.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to participation in the study.
- •Is scheduled to undergo Arthroscopic Rotator Cuff Repair, defined as arthroscopically assisted repair of any of the muscles or tendons comprising the rotator cuff.
- •If subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery per standard of care
- •Be at least 18, but not more than 80 years of age
- •Have an ASA risk class of I, II, or III according to the American Society of Anesthesiologists (ASA).
- •Have the ability to read and understand the study procedures and the use of the pain scales. Must have the ability to communicate meaningfully with the Study Investigator and staff.
- •Be free of other physical, mental, or medical conditions, which in the opinion of the Investigator, makes study participation inadvisable.
排除标准
- •Subjects requiring daily opioids equivalent to greater than 40 mg oxycodone for over 2 weeks prior to the study.
- •Has significant preexisting pulmonary (respiratory/breathing) disease, diaphragmatic paralysis or history of phrenic nerve injury (problems with the diaphragm causing breathing difficulties).
- •Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
- •Has known significant hypersensitivity to opioids, Ropivacaine, or the inactive ingredients (excipients) of the study medications.
- •Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years.
- •Has clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) based on medical history and examination.
- •Has participated in another clinical Study (investigational or marketed product within 30 days of surgery.
研究组 & 干预措施
A
Active Comparator
Initial Bolus 5 ml Ropivacaine
干预措施: Ropivacaine (Drug)
B
Active Comparator
Initial Bolus 10 ml Ropivacaine
干预措施: Ropivacaine (Drug)
C
Active Comparator
Initial Bolus 20 ml Ropivacaine
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Change in Diaphragmatic Displacement From Baseline to Post-surgery
时间窗: Baseline, Post anesthesia care unit (PACU) - within 8 hours
Diaphragm displacement from exhale to inhale. The baseline diaphragm measurement was obtained pre-operatively before the block was administered prior to surgery. This was again measured post-operatively before the patient's discharge from the Post-anesthesia Care Unit.
Pain Measurements Via Numeric Pain Rating Scales (NRS)
时间窗: Discharge, 24 h, 48h, 12 weeks
Pain was reported via NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
次要结局
- Percentage of Participants Who Considered the Analgesic Technique "Helpful" or "Extremely Helpful"(at 24 and 48 hours after discharge from the hospital)
- Functional Outcome - Simple Shoulder Test (SST)(Baseline, 12 weeks)
研究者
研究点 (2)
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