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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by St. Luke's-Roosevelt Hospital Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01355757
First received: May 16, 2011
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Rotator Cuff Injury
Device: Baxter INFUSOR System
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Baxter INFUSOR System
    Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01355757

Contacts
Contact: Admir Hadzic, MD PhD 212-665-1400 admir@nysora.com

Locations
United States, New York
St. Luke's-Roosevelt Hospital Not yet recruiting
New York, New York, United States, 10025
Contact: Admir Hadzic, MD PhD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Baxter Healthcare Corporation
Investigators
Principal Investigator: Admir Hadzic, MD PhD St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Admir Hadzic MD PhD, St. Luke's-Roosevelt Hospital
ClinicalTrials.gov Identifier: NCT01355757     History of Changes
Other Study ID Numbers: 10-142
Study First Received: May 16, 2011
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Luke's-Roosevelt Hospital Center:
shoulder arthroscopy
24-week follow-up
quality of life
rehabilitation achievement
rotator cuff repair

Additional relevant MeSH terms:
Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014