Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty

August 6, 2019 updated by: Kevin Stebler, University Hospital, Geneva
The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.

The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.

Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Recruiting
        • Departement of Anesthesia, Hôpitaux Universitaires de Genève
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for total knee athroplasty under general anesthesia
  • ASA 1-3

Exclusion Criteria:

  • Kidney disease with GFR < 50 ml/mn
  • Daily opioid consumption > 1 month
  • Allergy to local anesthetics
  • Neurological problems of the lower extremity
  • other contraindications to peripheral nerve blocks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Popliteal plexus block and continuous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
Other Names:
  • Continous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
Other Names:
  • Continous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.
Other Names:
  • Popliteal plexus block
Active Comparator: continuous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
Other Names:
  • Continous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
Other Names:
  • Continous femoral nerve block
Drug: Ropivacaine 0.5% Injectable Solution
Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.
Other Names:
  • Popliteal plexus block

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total iv morphine consumption (mg)
Time Frame: 12 postoperative hours
12 postoperative hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total iv morphine consumption (mg)
Time Frame: 24 and 48 postoperative hours
24 and 48 postoperative hours
Average and maximum pain scores (Numeric rating scale 0-10)
Time Frame: 12, 24 and 48 postoperative hours
12, 24 and 48 postoperative hours
Sciatic extension of popliteal plexus block
Time Frame: 2 and 24 postoperative hours
Presence of sensitive or/and motor sciatic extension of popliteal plexus block
2 and 24 postoperative hours
Plantarflexion and dorsiflexion ankle strength (Newtons)
Time Frame: 2 and 24 postoperative hours
2 and 24 postoperative hours
Knee pain localization (anterior, internal, posterior, lateral, medial)
Time Frame: 2, 12, 24 and 48 postoperative hours
2, 12, 24 and 48 postoperative hours
Popliteal plexus block procedure time (minutes)
Time Frame: When performing the popliteal plexus block
Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%
When performing the popliteal plexus block
Popliteal plexus block duration of action (hours)
Time Frame: up to 48 postoperative hours
Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale ≥ 4)
up to 48 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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