Back to resultsPost-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Primary Purpose
Rotator Cuff Injury
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Baxter INFUSOR System
Single Injection of Local Anesthetic
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injury focused on measuring shoulder arthroscopy, 24-week follow-up, quality of life, rehabilitation achievement, rotator cuff repair
Eligibility 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
Sites / Locations
- St. Luke's-Roosevelt Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Baxter INFUSOR System
Single Injection of Local Anesthetic
Arm Description
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Single injection of 20 ml ropivacaine 0.5%
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01355757
First Posted
May 16, 2011
Last Updated
May 16, 2014
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Baxter Healthcare Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01355757
Brief Title
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Official Title
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Baxter Healthcare Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
Keywords
shoulder arthroscopy, 24-week follow-up, quality of life, rehabilitation achievement, rotator cuff repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baxter INFUSOR System
Arm Type
Experimental
Arm Description
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Arm Title
Single Injection of Local Anesthetic
Arm Type
Active Comparator
Arm Description
Single injection of 20 ml ropivacaine 0.5%
Intervention Type
Device
Intervention Name(s)
Baxter INFUSOR System
Intervention Description
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Intervention Type
Drug
Intervention Name(s)
Single Injection of Local Anesthetic
Intervention Description
Single injection of 20 ml ropivacaine 0.5%
Primary Outcome Measure Information:
Title
Quality of Life
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, MD PhD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
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