Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 intraarticular and patellar tendon harvest site.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Rochester
• Collaborator: BREG, Inc
• Treatments: Anesthetics; Bupivacaine

Criteria

Inclusion Criteria:

• Subject symptoms

1. Daily pain

2. 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 Criteria:

• 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.