NCT03461679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

February 25, 2018

Last Update Submit

October 6, 2020

Conditions

Total Knee Replacements

Outcome Measures

Primary Outcomes (2)

  • Opioid consumption

    Morphine

    24 hours

  • Opioid consumption

    Morphine

    48 hours

Secondary Outcomes (6)

  • Muscle strength

    24 hours

  • Muscle strength

    48 hours

  • Time to up and go test

    24 hours

  • Time to up and go test

    48 hours

  • 30 Chair stand test

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Adductor canal block Femoral triangle block

Procedure: Adductor canal blockProcedure: Femoral triangle block

Standard

ACTIVE COMPARATOR

Femoral triangle block

Procedure: Femoral triangle block

Interventions

Adductor canal blockPROCEDURE

Single shot block with 0.5% bupivacaine 10mls

Intervention
Femoral triangle blockPROCEDURE

Single shot block with 0.5% bupivacaine 10mls

InterventionStandard

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 12, 2018

Study Start

February 22, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)