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

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ClinicalTrials.gov Identifier: NCT01355757
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : May 19, 2014
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Admir Hadzic, St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injury Device: Baxter INFUSOR System Drug: Single Injection of Local Anesthetic Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Study Start Date : June 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Admir Hadzic, Dr., St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01355757     History of Changes
Other Study ID Numbers: 10-142
First Posted: May 18, 2011    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Rotator Cuff Injuries
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Rupture
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents