Analgesic Effect of Adding an Adductor Canal Block to a F... | NCT03461679

Studies
Analgesic Effect of Adding an Adductor Canal Block to a Femoral Triangle Block for Total Knee Replacement

NCT03461679

Sponsor

Changi General Hospital

Status

Completed

Last Update Posted

Oct 8, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Total Knee Replacements

Interventions

Adductor canal block
Femoral triangle block

Countries

Singapore

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

Oct 2020

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 22, 2018Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Feb 25, 2018

First Submission Date that Met QC Criteria

Mar 5, 2018

First Posted Date

Mar 12, 2018Actual

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

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of the study is to investigate whether the addition of an adductor canal block to a femoral triangle block will provide better analgesia for patients after total knee replacements.

Detailed Description

Not provided

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Adductor canal block Femoral triangle block	Procedure: Adductor canal block Procedure: Femoral triangle block
Standard	Active Comparator	Femoral triangle block	Procedure: Femoral triangle block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adductor canal block	Procedure	Single shot block with 0.5% bupivacaine 10mls	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Opioid consumption	Morphine	24 hours
Opioid consumption	Morphine	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Muscle strength	measured with dynanometer	24 hours
Muscle strength	measured with dynanometer	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing total knee arthroplasty under spinal anaesthesia
45y or older
ASA 1-3
BMI 18-35

Exclusion Criteria:

Unable to consent
Chronic opioid consumption
Allergy to study medication
Lower limb surgery preceding year
Unable to complete baseline testing, pre-existing neurological deficit
Contraindication to spinal anaesthesia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changi General Hospital		Singapore		529889	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided