NCT03696095

Brief Summary

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4 postoperative-pain

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

April 16, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2018

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

September 28, 2018

Last Update Submit

January 24, 2019

Conditions

Postoperative PainPostoperative Complications

Keywords

total knee arthroplastypostoperative painprogrammed intermittent bolusContinuous femoral nerve block

Outcome Measures

Primary Outcomes (1)

  • Frequency of unplanned analgesia interventions.

    Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.

    up to 72 hours after surgery

Secondary Outcomes (4)

  • Pain difference

    up to 72 hours after surgery

  • Motor block frequency

    up to 72 hours after surgery

  • Mobilization quality during physiotherapy sessions.

    up to 72 hours after surgery

  • local anesthesia technique related complications

    until catheter removal 48 hours after surgery

Study Arms (2)

Continous infusion ropivacaine

ACTIVE COMPARATOR

Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ...

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)

PIB ropivacaine

EXPERIMENTAL

Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)

Interventions

Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)DRUG

programmed intermittent bolus 5ml each one hour.

Also known as: PIB
PIB ropivacaine
Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)DRUG

continuous infusion 6ml/h

Also known as: Continuous infusion
Continous infusion ropivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admitted for unilateral primary total knee arthroplasty.

You may not qualify if:

  • ASA score \> 3
  • BMI \> 40
  • refusal of loco-regional technique.
  • psychiatric disease.
  • inability to understand/ use the Local anesthetic delivery pump.
  • local anesthetic allergy,
  • porphyry,
  • uncontrolled epilepsy,
  • severe cardiac arrhythmia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Pain, PostoperativePostoperative Complications

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Annis Orfi

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 4, 2018

Study Start

April 16, 2018

Primary Completion

November 30, 2018

Study Completion

December 6, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Locations

BE(1)