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

This study has been completed.
Sponsor:
Collaborator:
BREG, Inc
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178178
First received: September 12, 2005
Last updated: June 25, 2015
Last verified: May 2015
  Purpose

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.

Condition Intervention
Pain, Postoperative
Device: Breg Pain Care 3000 Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Placebo Controlled, Prospective, Randomized Clinical Investigation of the Efficacy of Continuous Infusion Regional Anesthetic on Postoperative Pain Following Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 day ] [ Designated as safety issue: No ]
    Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.


Enrollment: 96
Study Start Date: March 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Bupivicaine 0.5% Intraaticulary Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
Device: Breg Pain Care 3000 Catheter
Drug: Bupivicaine 0.5 % Intraaticulary Only
Experimental: Drug: Bupivicaine 0.5% Patellar Tendon Site
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
Device: Breg Pain Care 3000 Catheter
Drug: Bupivicaine 0.5 % Patellar Tendon Site Only
Experimental: Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
Device: Breg Pain Care 3000 Catheter
Drug: Bupivicaine 0.5 % Intraarticular and Patellar Tendon Site
Placebo Comparator: Drug: Placebo
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
Device: Breg Pain Care 3000 Catheter
Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178178

Locations
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
BREG, Inc
Investigators
Principal Investigator: Robert D Bronstein, MD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178178     History of Changes
Other Study ID Numbers: Pain Catheter Study
Study First Received: September 12, 2005
Results First Received: April 9, 2015
Last Updated: June 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
anterior cruciate ligament reconstruction
Pain Care 3000
Catheter Placement
Pain
Breg, Inc

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics
Bupivacaine
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015