Proximal Versus Distal Adductor Canal Blocks for Total Kn... | NCT02701114

Studies
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

NCT02701114

Sponsor

Benaroya Research Institute

Status

Completed

Last Update Posted

Jul 13, 2017Actual

Enrollment

76Actual

Phase

Not Applicable

Conditions

Post-Operative Pain

Interventions

Proximal Adductor Canal Block
Distal Adductor Canal Block

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Feb 29, 2016

First Submission Date that Met QC Criteria

Mar 2, 2016

First Posted Date

Mar 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2017

Last Update Posted Date

Jul 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proximal	Active Comparator	Proximal Adductor Canal Block	Procedure: Proximal Adductor Canal Block
Distal	Active Comparator	Distal Adductor Canal Block	Procedure: Distal Adductor Canal Block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proximal Adductor Canal Block	Procedure	Continuous Nerve Block	Proximal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid Consumption (IV Morphine Equivalents)	Total opioid consumption	24 Hours

Secondary Outcomes

Measure	Description	Time Frame
Opioid Consumption (IV Morphine Equivalents)	Total opioid consumption	48 Hours
Pain (Numeric Rating)	NRS Pain Scale	48 Hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil A Hanson, MD	Virginia Mason Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Mason Medical Center		Seattle	Washington	98101	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29140959	Derived	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain