Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMay 19, 2014
May 1, 2014
1.6 years
May 16, 2011
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Baxter INFUSOR System
EXPERIMENTALRegional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Single Injection of Local Anesthetic
ACTIVE COMPARATORSingle injection of 20 ml ropivacaine 0.5%
Interventions
Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
Single injection of 20 ml ropivacaine 0.5%
Eligibility Criteria
You may qualify if:
- Patients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.
- Inclusive criteria are:
- years of age
- ASA physical status I-III
- BMI \< 35 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Luke's-Roosevelt Hospital
New York, New York, 10025, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Admir Hadzic, MD PhD
St. Luke's-Roosevelt Hospital Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 18, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
May 19, 2014
Record last verified: 2014-05