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Completed

NCT Number: NCT03696095

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Liege

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)

Drug

programmed intermittent bolus 5ml each one hour.

Other names: PIB

Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)

Drug

continuous infusion 6ml/h

Other names: Continuous infusion

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

J P Lecoq

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 4, 2018
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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