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

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Admir Hadzic, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01355757
First received: May 16, 2011
Last updated: May 16, 2014
Last verified: May 2014
  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
Drug: Single Injection of Local Anesthetic
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


Enrollment: 70
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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%
Active Comparator: Single Injection of Local Anesthetic
Single injection of 20 ml ropivacaine 0.5%
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
St. Luke's-Roosevelt Hospital
New York, New York, United States, 10025
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, Dr., St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01355757     History of Changes
Other Study ID Numbers: 10-142
Study First Received: May 16, 2011
Last Updated: May 16, 2014
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:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014