Rotator Cuff Injury
Conditions
Keywords
shoulder arthroscopy, 24-week follow-up, quality of life, rehabilitation achievement, rotator cuff repair
Brief summary
Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.
Interventions
DEVICEBaxter INFUSOR System
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
DRUGSingle Injection of Local Anesthetic
Single injection of 20 ml ropivacaine 0.5%
Sponsors
Baxter Healthcare Corporation
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 24 weeks | 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 |
Countries
United States
Outcome results
None listed