Assessing Function and Pain After Total Knee Arthroplasty With Combined Femoral and Popliteal Nerve Block

January 11, 2024 updated by: University of Haifa

The goal of this interventional study is to examine whether a pain management technique of combined femoral and popliteal nerve block is effective in total knee arthroplasty patients. The main questions it aims to answer are:

Are there differences in postoperative outcomes? Does the nerve block, age, preoperative quadriceps muscle strength and Oxford Knee Score of the patient predict early functional ability? Participants underwent total knee arthroplasty and assessments. Researchers compared pain management techniques to assess effects on postoperative outcomes and identified the importance of preoperative variables a predictors of early functional ability. Further research is required to refine postoperative pain management strategies.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
34

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 Locations

  • Israel
      • Nahariya, Israel, 22000
        • Galilee Medical Centre

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over the age of 18
  • Electively assigned for primary knee replacement surgery.
  • The American Society of Anesthesiologists physical status score 1-3.

Exclusion Criteria:

  • Revision surgery.
  • Patients suffering from chronic pain syndrome or chronic opioid use.
  • Patients with previous neurological deficits in the lower extremities.
  • A cognitive state that does not allow signing of consent or understanding simple instructions.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: Control group
Patients undergoing total knee arthroplasty and didn't receive pain block.
Experimental: Combined Femoral and Popliteal nerve block
Patients who receive a Patients undergoing total knee arthroplasty received a combined femoral and popliteal nerve block (single-shot of each) during the surgical procedure.
Procedure: Combined Femoral and Popliteal nerve block
Patients who receive a combined femoral and popliteal nerve block during surgery, fill out a questionnaire and undergo a muscle strength test before surgery, undergo functional tests, a muscle strength test and are asked about pain intensity after surgery.

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
Measure Description
Time Frame
Timed up & go Test
Time Frame: First day after surgery and third or fourth day after surgery
Total time to arise from chair, walk 3 m, turn around, return to chair and sit down. Two trials performed and the faster of the two is recorded to the nearest 10th of a second.
First day after surgery and third or fourth day after surgery
Numeric Pain Rating Scale
Time Frame: up to four days after surgery
An 11-point scale scored from 0 to 10: 0 = no pain, 10= the most intense pain imaginable
up to four days after surgery
Quadriceps Muscle Strength
Time Frame: A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .
muscle strength measure by dynamometer (N⋅m)
A 1 day before the surgery, first day after the surgery and third or fourth day after the surgery .

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
Elderly Mobility Scale
Time Frame: First day after the surgery and third or fourth day after the surgery
The Elderly Mobility Scale is a 20 point validated assessment tool for the assessment of frail elderly subjects. The The Elderly Mobility Scale is measured on an ordinal scale of 0-20, when Scores under 10 - generally these patients are dependent in mobility maneuvers; require help with basic activity of daily living, such as transfers, toileting and dressing. Scores between 10 - 13 - generally these patients are borderline in terms of safe mobility and independence in activity of daily living i.e. they require some help with some mobility maneuvers. Scores over 14 - Generally these patients are able to perform mobility maneuvers alone and safely and are independent in basic activity of daily living.
First day after the surgery and third or fourth day after the surgery
5 Times Sit to Stand Test
Time Frame: First day after the surgery and third or fourth day after the surgery
The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times.
First day after the surgery and third or fourth day after the surgery
Hospitalization Duration
Time Frame: At discharge (assessed up to day 10)
Number of days of hospitalization after the surgery- taken from the pa...
At discharge (assessed up to day 10)
Surgery Duration
Time Frame: During the surgery
minutes- taken from the patient's file
During the surgery
Consumption of Analgesics
Time Frame: At discharge (assessed up to day 10)
taken from the patient's file
At discharge (assessed up to day 10)
Occurrence of Falls
Time Frame: At discharge (assessed up to day 10)
throughout the hospitalization- taken from the patient's file
At discharge (assessed up to day 10)
Oxford Knee Score Questionnaire
Time Frame: A 1 day before the surgery
The Oxford Knee Score is a patient self-completion patient-reported outcome containing 12 questions on activities of daily living. It provides a single summed score which reflects the severity of problems that the respondent has with their knee. The Oxford Knee Score is scored 0-48 when Score 0-19 May indicate severe knee arthritis. Score 20-29 May indicate moderate to severe knee arthritis. Score 30-39 May indicate mild to moderate knee arthritis. Score 40-48 May indicate satisfactory joint function.
A 1 day before the surgery

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 of Haifa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Western Galilee Hospital-Nahariya

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.
November 1, 2022

Primary Completion (Actual)

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.
July 14, 2023

Study Completion (Actual)

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.
August 14, 2023

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).
December 25, 2023

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.
December 25, 2023

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.
January 9, 2024

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.
January 12, 2024

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.
January 11, 2024

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.
December 1, 2023

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.
  • UHaifa-FPNB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Rehabilitation

Clinical Trials on Combined Femoral and Popliteal nerve block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings