Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty

March 4, 2013 updated by: Saint Francis Care

Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement

The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee arthroplasty
  • ages 18-80

Exclusion Criteria:

  • history of neurological disease
  • diabetes
  • pregnancy
  • neuropathy
  • chronic narcotic use
  • allergy to local anesthetic solution or NSAIDS
  • inability to give consent or cooperate with the study protocol

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: Canal Block and Capsular Injection
Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.
Procedure: Canal Block and Capsular Injection
Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.
Active Comparator: Femoral with Tibial Nerve Block
Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.
Procedure: Femoral Nerve Block with Tibial Nerve Block
Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to ambulate post operatively.
Time Frame: Up to 3 days (72 hours) post surgery.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Up to 3 days (72 hours) post surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores at rest and with knee flexion.
Time Frame: Up to 3 days ( 72 hours) after surgery
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Time Frame: Up to 3 days (72 hours) post surgery
Amount of opioid consumption post surgery for 72 hours.
Up to 3 days (72 hours) post surgery

Collaborators and Investigators

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

Sponsor

Saint Francis Care

Investigators

  • Principal Investigator: Sanjay Sinha, M.D., Saint Francis Memorial Hospital

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

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-09-003

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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