A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty

October 22, 2015 updated by: Jaime Baratta, Thomas Jefferson University

A Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Intra-articular Catheter (IAC) Following Primary Total Knee Arthroplasty

The study is a prospective randomized controlled trial comparing intraarticular catheters and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr > 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score (form included), WOMAC score (form included) and baseline Pain Management Questionnaire. When designated through randomization, intra-articular catheters will be placed intraoperatively by the surgeons, per usual protocol. ACC's will be placed postoperatively in the PACU. The catheters will exit the bandage in a similar fashion to blind the personnel collecting data, postoperatively. Those collecting data will not be blinded from identifying patients in the control group, as no catheter will exit the bandage. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 40-85
  • American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3.
  • Undergoing Unilateral, Primary, Total Knee Arthroplasty
  • English as native language

Exclusion Criteria:

  • Patient refusal
  • History of opioid dependence
  • Contraindication to peripheral nerve block
  • Pre-existing significant neuropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor Canal Catheter
Postoperatively, patients will be brought to the PACU. The needle insertion site, approximately 10cm proximal to their operative knee, will be exposed. A sterile field will be utilized and the femoral artery is identified with a high frequency linear transducer proximal to the operative knee. 18g insulated Tuohy needle will be inserted in an out-of-plane approach through the sartorius muscle to a final location in close proximity to the saphenous nerve. Once satisfied with needle placement and following negative aspiration, 15 cc's of 0.5% ropivicaine will be injected through the needle under visualization. A 20-g multi-orifice catheter will be inserted approximately 4 cm beyond the needle tip and secured.
Drug: Ropivicaine
Procedure: Adductor Canal Catheter
0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump
Experimental: Intraarticular Catheter
Intra-articular catheters will be placed by the surgeon at the end of the procedure, before wound closure. A bupivacaine 0.5% infusion will be admin through the On-Q system and continued for 48 hours postoperatively.
Drug: Bupivicaine
Procedure: Intraarticular Catheter
0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: immediately postoperative period to post-operative day # 2
postoperative pain as measured by Visual Analog Scale at rest and with movement
immediately postoperative period to post-operative day # 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: immediat postoperative period to postoperative day # 2
Opioid consumption within hospitalization
immediat postoperative period to postoperative day # 2
Chronic post-surgical pain
Time Frame: 6-8 weeks post-operative
Assess post-surgical pain and function as measured by PainDetect and WOMAC questionnaires at 6-8 weeks post-operative compared to preoperative pain and function
6-8 weeks post-operative
Participation in Physical therapy
Time Frame: immediate postoperative period to postoperative day #2
Physical therapy benchmarks such as active and passive range of motion
immediate postoperative period to postoperative day #2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Jaime L Baratta, MD, Sidney Kimmel Medical Center at Thomas Jefferson University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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