Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Rotator Cuff Injury Clinical Trial

Official title:

Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355757
• Other study ID #: 10-142
• Status: Completed
• Phase: Phase 0
• First received: May 16, 2011
• Last updated: May 16, 2014
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Injury

Intervention

Device:
• Baxter INFUSOR System
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia

Drug:
• Single Injection of Local Anesthetic
Single injection of 20 ml ropivacaine 0.5%

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

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