Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses Arthroplasty

March 17, 2024 updated by: Seda Kurtbeyoğlu, Kecioren Education and Training Hospital

Adductor Canal Block Versus Femoral Nerve Block With Repeated Bolus Doses: Postoperative Analgesia and Functional Outcomes After Total Knee Arthroplasty

After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.

investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee replasment under spinal anesthesia in this study.

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.

Detailed Description

After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses.

investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee revision under spinal anesthesia in this study. Materials and Methods: The patient will be informed about the procedure to be performed before the operation and written approval will be given. The patient will be premeditated with 2mg midazolam and sedayon and monitored according to routine operating room procedures and total knee prosthesis operation under spinal anesthesia. Patients will then be transferred to the collection room and ECG, NIBP and SpO2 monitoring and appropriate sterilization will be performed, and a grubby femoral nerve catheter with USG will be attached to the other group adductor channel catheter. A 20cc 0.25% marcain will be administered in 6 hours, with the first dose catheter placed in both groups.

In the compilation unit, the patient will be infused with IV PCA in the morphine. The bolus dose of 1 mg IV of the PC will be adjusted to the duration of 10 minutes of lockout. Postoperatively, 3x1 metoclopramide, 4x1 gr / 24h IV paracetamol and 3x50 mg / 24h IV dexketoprofen will be administered to each patient.

In this process, demographic information of the patients, peroperative KH, ABP, SpO2 values will be recorded. In the postoperative period, the patient's pain level, opioid requirement, motor block and muscle strength will be recorded and compared statistically.

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.
42

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

  • Turkey
    • Kecioren
      • Ankara, Kecioren, Turkey, 06380
        • SEDA

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA1-2-3 patients
  • older than 55 years
  • who undergo elective total knee prosthesis in our hospital

Exclusion Criteria:

  • ASA IV patients ,
  • patients with local anesthesia that we use,
  • patients with coagulation disorders,
  • patients with anatomical anomalies,
  • patients with localized infection in the injection site ,
  • patients who is incapable of using pca and/ or evaulate VAS scale,
  • patients with peripheral nerve disease,
  • patients with different surgical planning,
  • complicated gonarthrosis patients,
  • revision planned patients,
  • patients who refuse to be involved in the study

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.
Active Comparator: femoral nerve block
Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Procedure: femoral nerve block
The probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Active Comparator: adductor canal block
Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Procedure: Adductor Canal Block
Adductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
Other Names:
  • saphen nerve 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
Measure Description
Time Frame
Postoperative Muscle strength- Quadriceps Muscle strength scale
Time Frame: postoperative 48 hour
Quadriceps Muscle strength scale
postoperative 48 hour

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
postoperative analgesia - Visual analog scale
Time Frame: 72 hour
Visual analog scale
72 hour

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.
Kecioren Education and Training Hospital

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.
April 5, 2017

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.
December 30, 2017

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.
December 31, 2017

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).
April 4, 2017

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.
June 14, 2017

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.
June 15, 2017

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.
March 19, 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.
March 17, 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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 1 (Other Identifier: Mobile Health and Wellness Program)

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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