Adductor Canal Block for Medial Compartment Knee Arthroplasty

September 12, 2018 updated by: Wake Forest University Health Sciences

Evaluation of Ultrasound-Guided Adductor Canal Blockade for Postoperative Analgesia Following Robotic Medial Unicompartmental Knee Replacement

This study will evaluate the affects of a single injection ultrasound-guided adductor canal block for patients undergoing robotic-assisted (MAKOplasty) medial UKA (unicompartmental knee arthroplasty). Specifically, this study will compare the adequacy of postoperative analgesia provided by the adductor canal block with that provided by single injection lumbar plexus blockade. The working hypothesis is that the analgesia provided by the adductor canal block will be equivalent to the analgesia provided by the lumbar plexus block. The primary outcome will be a comparison of verbal numerical pain scores at rest and with movement over the first 24 hours following nerve blockade.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist 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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-85
  • Undergoing unilateral robotic-assisted (MAKOplasty) medial compartment knee arthroplasty at Wake Forest University Baptist Medical Center.
  • Must give written informed consent for anesthesia including subarachnoid blockade and peripheral nerve blockade of both the lumbar plexus and adductor canal.
  • Must consent to the performance of a sham block at the site to which they are not randomized.
  • Must also be reliable to give accurate verbal pain scores postoperatively.

Exclusion Criteria:

  • Contraindication to adductor canal blockade or lumbar plexus blockade (including significant coagulation abnormalities)
  • History of opioid addiction or current chronic pain therapy for pain other than at the surgical site that is being treated with high-dose opioids (extended release opioids or > 40mg oxycodone equivalents per day)
  • Allergy to study medications
  • Failure to adequately place either the adductor canal or lumbar plexus blocks.
  • Patients who decline or have a contraindication to subarachnoid blockade will also be excluded from the study.
  • Pregnancy.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adductor canal block
Patients in this arm will receive an adductor canal block prior to undergoing a medial compartment knee arthroplasty.
Drug: Adductor canal block
Other Names:
  • Saphenous nerve block
Active Comparator: Lumbar plexus block
Patients in this arm will receive a lumbar plexus block prior to undergoing a medial compartment knee arthroplasty.
Drug: Lumbar plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verbal Pain Scores at 6 Hours Post Nerve Blockade.
Time Frame: 6 hours post block.
Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.
6 hours post block.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 6, 12, 18, and 24 hours
Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.
6, 12, 18, and 24 hours
Time to First Analgesic
Time Frame: 24 hours
Time to first analgesic between two groups: adductor canal block and lumbar plexus block.
24 hours
Opioid Related Side Effects
Time Frame: 6, 12, 18, and 24 hours
Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.
6, 12, 18, and 24 hours
Quadriceps Motor Strength
Time Frame: 6 hours
Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes.
6 hours

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

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

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00023002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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