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Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

Primary Purpose

Post-Operative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proximal Adductor Canal Block

Distal Adductor Canal Block

About this trial

This is an interventional treatment trial for Post-Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Unilateral Total Knee Arthroplasty
ASA physical status I-III
>18 years old
Non-pregnant
Consent to participate in the study

Exclusion Criteria:

Refusal to participate
<18 years old
Chronic opioid use
Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic

Sites / Locations

Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Proximal

Distal

Arm Description

Proximal Adductor Canal Block

Distal Adductor Canal Block

Outcomes

Primary Outcome Measures

Opioid Consumption (IV Morphine Equivalents)

Total opioid consumption

Secondary Outcome Measures

Opioid Consumption (IV Morphine Equivalents)

Total opioid consumption

Pain (Numeric Rating)

NRS Pain Scale

Quadriceps Strength (% of Baseline)

Maximum Isometric Voluntary Contraction

Distance Ambulated (Feet)

Total distance ambulated during physical therapy

Full Information

NCT ID

NCT02701114

First Posted

February 29, 2016

Last Updated

July 11, 2017

Sponsor

Benaroya Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02701114

Brief Title

Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

Official Title

A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benaroya Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.

Detailed Description

This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Operative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proximal

Arm Type

Active Comparator

Arm Description

Proximal Adductor Canal Block

Arm Title

Distal

Arm Type

Active Comparator

Arm Description

Distal Adductor Canal Block

Intervention Type

Procedure

Intervention Name(s)

Proximal Adductor Canal Block

Intervention Description

Continuous Nerve Block

Intervention Type

Procedure

Intervention Name(s)

Distal Adductor Canal Block

Intervention Description

Continuous Nerve Block

Primary Outcome Measure Information:

Title

Opioid Consumption (IV Morphine Equivalents)

Description

Total opioid consumption

Time Frame

24 Hours

Secondary Outcome Measure Information:

Title

Opioid Consumption (IV Morphine Equivalents)

Description

Total opioid consumption

Time Frame

48 Hours

Title

Pain (Numeric Rating)

Description

NRS Pain Scale

Time Frame

48 Hours

Title

Quadriceps Strength (% of Baseline)

Description

Maximum Isometric Voluntary Contraction

Time Frame

48 Hours

Title

Distance Ambulated (Feet)

Description

Total distance ambulated during physical therapy

Time Frame

48 Hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unilateral Total Knee Arthroplasty ASA physical status I-III >18 years old Non-pregnant Consent to participate in the study Exclusion Criteria: Refusal to participate <18 years old Chronic opioid use Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil A Hanson, MD

Organizational Affiliation

Virginia Mason Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29140959

Citation

Meier AW, Auyong DB, Yuan SC, Lin SE, Flaherty JM, Hanson NA. Comparison of Continuous Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Noninferiority Trial. Reg Anesth Pain Med. 2018 Jan;43(1):36-42. doi: 10.1097/AAP.0000000000000692.

Results Reference

derived

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Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

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