Comparison of Pain Relief After Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty.
1 other identifier
observational
85
1 country
1
Brief Summary
- 1.Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used.
- 2.Ultrasound can help proper placement of catheter without relying on nerve stimulation.
- 3.The plan of the study is to compare two techniques head to head to see if they are equally effective or one is better than others.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2010
Longer than P75 for all trials
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 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 13, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 1, 2016
October 1, 2016
5.1 years
May 11, 2010
October 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
Pain will be monitored over the next 2-3 days while subjects have catheter inplace. Sleep, total oral analgesic intake will be compared.
2-3 days after surgery
Study Arms (2)
US Group
Interscalene catheter will be placed with US guidance without any nerve stimulation guidance.
NS Group
Catheter will be placed using nerve stimulation guidance
Eligibility Criteria
all subjects having total shoulder arthroplasty.
You may qualify if:
- yr or older
- patient agreed to continuous regional block
You may not qualify if:
- minor
- patient refusal
- any neuropathy
- allergies to local anesthetic,
- inability to obtain informed consent for any reason, Opioid user, chronic pain patients or unanticipated procedure other than total shoulder arthroplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Hospitals
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TARIQ MALIK, MD
University of Chicago
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 13, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 1, 2016
Record last verified: 2016-10