Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty

December 8, 2016 updated by: Yale University

Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty

The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Study Type

Interventional

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
  • The patient will need to be able to have decision-making capacity and ability to consent for the study.

Exclusion Criteria:

  • Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
  • Patients unable to have decision-making capacity and ability to consent for the study.

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
Active Comparator: adductor canal block (ACB)
Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.
Procedure: Continuous proximal adductor canal block
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Other Names:
  • ACB
Active Comparator: femoral nerve block (FNB)
Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.
Procedure: Continuous femoral nerve block
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Other Names:
  • FNB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor effects
Time Frame: 24 hours (postoperatively)
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
24 hours (postoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: On average between 6 and 8 hours postoperatively
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
On average between 6 and 8 hours postoperatively
Pain score
Time Frame: 24 hours (postoperatively)
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
24 hours (postoperatively)
Opioid consumption
Time Frame: On average between 6 and 8 hours postoperatively
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
On average between 6 and 8 hours postoperatively
Opioid consumption
Time Frame: 24 hours (postoperatively)
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
24 hours (postoperatively)
Motor effects
Time Frame: On average between 6 and 8 hours postoperatively
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
On average between 6 and 8 hours postoperatively

Collaborators and Investigators

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

Sponsor

Yale University

Investigators

  • Principal Investigator: Richa Wardham, MD, Yale School of Medicine

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

September 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508016335

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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