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

NCT00178178 | Completed Results

• 1 other identifier: Pain Catheter Study
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation will evaluate the subjective effect on postoperative pain of three catheter placements in the knee:

1. 1.intraarticular infusion only,
2. 2.patellar tendon harvest site only,
3. 3.both intraarticular and patellar tendon harvest site.

Conditions

Pain, Postoperative

Keywords

anterior cruciate ligament reconstruction; Pain Care 3000; Catheter Placement; Pain; Breg, Inc

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  3 day

Study Arms (4)

Drug: Bupivicaine 0.5% Intraaticulary Only

EXPERIMENTAL

Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Intraaticular 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%

Drug: Bupivicaine 0.5% Patellar Tendon Site

EXPERIMENTAL

Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Patellar Tendon Site Only 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%

Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon

EXPERIMENTAL

Breg Pain Care 3000 Catheter;Bupivicaine 0.5%; Intraarticular and Patellar Tendon Sites 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%

Drug: Placebo

PLACEBO COMPARATOR

Breg Pain Care 3000 Catheter with 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; Drug: Placebo

Interventions

Breg Pain Care 3000 Catheter DEVICE

Device: Breg Pain Care 3000 Catheter

Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon; Drug: Bupivicaine 0.5% Intraaticulary Only; Drug: Bupivicaine 0.5% Patellar Tendon Site; Drug: Placebo

Bupivicaine 0.5% DRUG

Drug: Bupivicaine 0.5 %

Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon; Drug: Bupivicaine 0.5% Intraaticulary Only; Drug: Bupivicaine 0.5% Patellar Tendon Site

Placebo DRUG

Drug: Placebo

Drug: Placebo

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• BREG, Inc: collaborator

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Robert Bronstein
• Organization: University of Rochester

robert_bronstein@urmc.rochester.edu

585-275-1024

Study Officials

• Robert D Bronstein, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 11, 2015
• Results First Posted: May 18, 2015

Record last verified: 2015-08

Locations

US (1)