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

• ClinicalTrials.gov Identifier: NCT03696095
• Recruitment Status: Completed
• First Posted: October 4, 2018
• Last Update Posted: January 25, 2019
• Sponsor: J P Lecoq
• Information provided by (Responsible Party): J P Lecoq, University of Liege

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Postoperative Complications	Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode); Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: April 16, 2018
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: December 6, 2018

Arms and Interventions

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 Name: 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 Name: PIB

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Motor block frequency [ Time Frame: up to 72 hours after surgery ]
   Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
3. 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).
4. 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Belgium

CHU Liege

Liège, Belgium, 4000

Sponsors and Collaborators

J P Lecoq

Investigators

• Principal Investigator: Annis Orfi; University of Liege

More Information

• Responsible Party: J P Lecoq, MD, University of Liege
• ClinicalTrials.gov Identifier: NCT03696095
• Other Study ID Numbers: 2018-000822-70
• First Posted: October 4, 2018
• Last Update Posted: January 25, 2019
• Last Verified: January 2019

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

Keywords provided by J P Lecoq, University of Liege:

total knee arthroplasty; postoperative pain; programmed intermittent bolus; Continuous femoral nerve block

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents