Efficacy of Continuous Infusion Ropivacaine Interscalene Blocks
Completed · Phase 4 · Has a placebo group
Conditions studied: Full-thickness Rotator Cuff Tear
In brief
Arthroscopic rotator cuff repair is a common and painful procedure routinely performed on an outpatient basis. Postoperative pain control regimens can include narcotic pain medicine, non-steroidal anti-inflammatory medications and regional anesthesia such as an interscalene block (ISB). Regional blocks such as ISB can safely provide complete pain relief for the shoulder and upper extremity for eight to twelve hours1. However, the shoulder is still very painful when the block wears off. The purpose of this study is to: 1. Examine the efficacy of continuous infusion scalene block ropivacaine catheters during the first two days after arthroscopic rotator cuff repair. 2. Examine narcotic consumption after continuous infusion scalene block ropivacaine and placebo catheters after arthroscopic rotator cuff repair. 3. Evaluate for any continued pain relief benefit of continuous infusion scalene block ropivacaine catheters during the three days after the infusion catheters have finished.
Key facts
- Study ID
- NCT02462382
- Run by
- Orlando Health, Inc.
- People needed
- 51
- Starts
- 2013-09-01
- Expected to finish
- 2016-05-20
- Last updated by the study team
- 2020-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.
You may not qualify if…
- Prior surgery on the involved shoulder
- Preoperative MRI suggesting that the rotator cuff tear is irreparable
- Patients with known allergies to oxycodone, ropivacaine or a similar drug
- Workman's compensation patients
- Patients who do not fill out their visual analog scores or their medication diaries
- Patients with labral or subscapularis tears requiring repair
Where it is running
- Orlando Orthopaedic Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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