Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

Sponsor:

Collaborators:

Information provided by (Responsible Party):

J P Lecoq，University Hospital of Liege

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

April 16, 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of unplanned analgesia interventions.[ Time Frame: up to 72 hours after surgery ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Pain difference[ Time Frame: up to 72 hours after surgery ]
Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.
Motor block frequency[ Time Frame: up to 72 hours after surgery ]
Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
Mobilization quality during physiotherapy sessions.[ Time Frame: up to 72 hours after surgery ]
accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).
local anesthesia technique related complications[ Time Frame: until catheter removal 48 hours after surgery ]
rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.

Descriptive Information

Brief Title ^ICMJE

Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

Official Title ^ICMJE

Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.

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.

Detailed Description

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. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
programmed intermittent bolus 5ml each one hour.
Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
continuous infusion 6ml/h

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - admitted for unilateral primary total knee arthroplasty. Exclusion Criteria: - 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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

J P Lecoq，University Hospital of Liege

Study Sponsor ^ICMJE

J P Lecoq

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Annis Orfi University Hospital of Liege

PRS Account

University Hospital of Liege

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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