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

Phase 4

Completed

• Conditions: Postoperative Pain; Postoperative Complications
• Interventions: Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode); Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)

• Registration Number: NCT03696095
• Lead Sponsor: J P Lecoq

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 Timeline

• Study Start: 2018-04-16
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Frequency of unplanned analgesia interventions.	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.

Secondary Outcome Measures

Name	Time	Method
Pain difference	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	up to 72 hours after surgery	Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
Mobilization quality during physiotherapy sessions.	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	until catheter removal 48 hours after surgery	rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.

Trial Locations

Locations (1)

CHU Liege; 🇧🇪 Liège, Belgium