Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks: A Randomized, Triple-Masked, Placebo-Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Passive glenohumeral abduction, as evaluated using standard goniometry restricting scapular movement in a supine position. The difference in abduction the day following manipulation compared with the pre-manipulation value, expressed as a percentage.
研究概览
简要总结
Research study to determine if putting local anesthetic through a tiny tube next to the nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder procedure performed on the frozen shoulder. It will also help determine if patients have a higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their post-procedure pain control.
详细描述
Primary Specific Aim: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in increased shoulder abduction following treatment for adhesive capsulitis of the shoulder.
Hypothesis
Following shoulder manipulation under a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve blcok to usual and customary post-manipulation analgesia will result in a significantly greater shoulder abduction improvement the day following the manipulation.
Secondary Specific Aims: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in an increased quality-of-life and shoulder range-of-motion, as well as a decreased chronic pain following treatment for adhesive capsulitis of the shoulder.
Hypothesis 1: Following shoulder manipulation under a single-injection interscalene blcok for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and customary post-manipulation analgesia will result in a significantly increased quality-of-life improvement and shoulder range-of-motion compared wiht baseline values after three months.
Hypothesis 2: Following shoulder manipulation undera a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and costomary post-manipulation analgesia will result in a significantly decreased chronic pain compared with basedline falues after three months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing theraputic manipulation for adhesive capsulitis of the shoulder
- •age 18 years or older
- •accepting a single-injection nerve block for manipulation
- •understanding possible perineural infusion-related complications, study protocol, and catheter/pump care
- •having caretaker through the first night after manipulation
- •having an ASA physical status classification of 1-3
排除标准
- •Any contraindications for a CISB
- •any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery
- •known allergy or other contraindication to the study medications
- •pregnancy
- •known hepatic or renal insufficiency/disease
- •peripheral neuropathy of the surgical extremity
- •morbid obesity
- •inability to communicate with the investigators and hospital staff
- •moderate-to-severe shoulder arthritis
- •immunocompromised status of any etiology
- •incarceration
研究组 & 干预措施
1. 0.2% Ropivicaine perinueral infusion
Patients will receive normal standard of care post-manipulation (single-injection brachial plexus nerve block, oral analgesics, and cold therapy). They will then be randomized to 0.2% Ropivicaine attached to the perineural catheter and an infusion will be initiated. The outcome measures will be assessed by study staff on the phone and at regular visits to the surgeon's office.
干预措施: Interscalene catheter with Ropivicaine or normal saline (Procedure)
2. Normal Saline perineural infusion
Patients will receive normal standard of care post-manipulation (single-injection brachial plexus nerve block, oral analgesics, and cold therapy). They will then be randomized to normal saline attached to the perineural catheter and an infusion will be initiated. The outcome measures will be assessed by study staff on the phone and at regular visits to the surgeon's office.
干预措施: Interscalene catheter with Ropivicaine or normal saline (Procedure)
结局指标
主要结局
Passive glenohumeral abduction, as evaluated using standard goniometry restricting scapular movement in a supine position. The difference in abduction the day following manipulation compared with the pre-manipulation value, expressed as a percentage.
时间窗: change from baseline: measured immediately prior to manipulation and the morning following the manipulation.
次要结局
未报告次要终点
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego