Rotator Cuff Injury Clinical Trial
Official title:
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form. Inclusive criteria are: - 18-75 years of age - ASA physical status I-III - BMI < 35 kg/m2 Exclusion Criteria: - all open shoulder procedures - patient having difficulty understanding the instruction on using the anesthetic infusion pump - contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy) - significant neurologic disorders of the upper extremity - psychiatric or cognitive disorders - history of substance abuse or chronic opioid use |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. Luke's-Roosevelt Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
St. Luke's-Roosevelt Hospital Center | Baxter Healthcare Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life | To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life | 24 weeks | No |
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