N/A
N=96
Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00178178 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Pain — 24; 24; 24; 24 participants that experienced pain
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breg Pain Care 3000 Catheter (Device); Bupivicaine 0.5% (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
24; 24; 24; 24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00178178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.