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

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.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode); Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)

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: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 ...	Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode); continuous infusion 6ml/h; Other Names: Continuous infusion
Experimental: PIB ropivacaine; 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); programmed intermittent bolus 5ml each one hour.; Other Names: PIB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: J P Lecoq
• Investigators: Principal Investigator: Annis Orfi, University of Liège

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: total knee arthroplasty; postoperative pain; programmed intermittent bolus; Continuous femoral nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Pain, Postoperative; Postoperative Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2018-000822-70

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No