Status:
COMPLETED
Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
BREG, Inc
Conditions:
Pain, Postoperative
Eligibility:
All Genders
15-65 years
Phase:
NA
Brief Summary
This investigation will evaluate the subjective effect on postoperative pain of three catheter placements in the knee: 1. intraarticular infusion only, 2. patellar tendon harvest site only, 3. both i...
Detailed Description
There will be 96 subjects recruited into this study. Based on power analysis for repeated measures analysis of variance, the sample size required for this investigation is 24 subjects per group based ...
Eligibility Criteria
Inclusion
- Subject symptoms
- Daily pain
- Pain restricts work, recreation and/or activities of daily living (ADL)
- Cognitive function sufficient to understand protocol and to complete subject diary or other analysis tools employed.
- Must read, write, and understand the English language.
- American Society of Anesthesiologists (ASA) risk 1 or 2
- Gender - Both
- Age 15 - 65 years (parental consent will be obtained on all subjects under age 18).
- Provided written informed consent
Exclusion
- Neuropathic joint
- Remote source of ongoing sepsis
- Severe vascular disease
- Any medical condition precluding safe anesthesia, surgery, or rehabilitation
- Comorbid conditions preventing full functional activity or which require continuous use of pain medication.
- A known history of allergy, sensitivity, or any other form of reaction to local anesthetics of the amide type, acetaminophen, or opioids.
- Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease, as judged by the investigator.
- A neurological and/or vascular condition which may affect the outcome of the procedure.
- Receiving regular treatment with analgesics, sedatives, or any other medication with central nervous system effects.
- Tendency to bleed
- Women who are pregnant or are not practicing medically acceptable contraception (a pregnancy test is used pre-operatively as part of standard of care).
- Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00178178
Start Date
March 1 2005
End Date
November 1 2007
Last Update
September 11 2015
Active Locations (1)
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1
Strong Memorial Hospital
Rochester, New York, United States, 14642