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

Primary Purpose

Postoperative Pain, Postoperative Complications

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
Sponsored by
J P Lecoq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Liege

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continous infusion ropivacaine

PIB ropivacaine

Arm Description

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 ...

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain difference
Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.
Motor block frequency
Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
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).
local anesthesia technique related complications
rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.

Full Information

First Posted
September 28, 2018
Last Updated
January 24, 2019
Sponsor
J P Lecoq
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1. Study Identification

Unique Protocol Identification Number
NCT03696095
Brief Title
Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J P Lecoq

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Complications
Keywords
total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continous infusion ropivacaine
Arm Type
Active Comparator
Arm Description
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 ...
Arm Title
PIB ropivacaine
Arm Type
Experimental
Arm Description
Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
Other Intervention Name(s)
PIB
Intervention Description
programmed intermittent bolus 5ml each one hour.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
Other Intervention Name(s)
Continuous infusion
Intervention Description
continuous infusion 6ml/h
Primary Outcome Measure Information:
Title
Frequency of unplanned analgesia interventions.
Description
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.
Time Frame
up to 72 hours after surgery
Secondary Outcome Measure Information:
Title
Pain difference
Description
Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.
Time Frame
up to 72 hours after surgery
Title
Motor block frequency
Description
Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
Time Frame
up to 72 hours after surgery
Title
Mobilization quality during physiotherapy sessions.
Description
accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).
Time Frame
up to 72 hours after surgery
Title
local anesthesia technique related complications
Description
rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.
Time Frame
until catheter removal 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annis Orfi
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

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

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