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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2018-12-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery

NCT03698006

Postoperative Pain Knee Osteoarthritis

COMPLETED NA

Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty

NCT00803348

Knee Arthroplasty

COMPLETED NA

Continuous Local Anesthesia Versus Continuous Femoral Nerve Bloc After Total Knee Arthroplasty: Impact on Mean Discharge Aptitude Delay

NCT02006355

Total Knee Arthroplasty

TERMINATED PHASE4

Regional Anesthesia for Knee Prothesis Surgery

NCT02451605

Total Knee Replacement

UNKNOWN NA

Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty

NCT03372265

Postoperative Pain

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 ...

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

continuous infusion 6ml/h

PIB ropivacaine

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

programmed intermittent bolus 5ml each one hour.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

programmed intermittent bolus 5ml each one hour.

Intervention Type DRUG

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

continuous infusion 6ml/h

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PIB Continuous infusion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No