ESPB and ACB in Knee Arthroplasty

November 10, 2022 updated by: İnal Bensu Arıoglu, Istanbul Medeniyet University

Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Adductor Canal Block on Postoperative Pain, Opioid Consumption and Quadriceps Muscle Strength in Total Knee Arthroplasty Surgery

Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.

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

In a prospective, randomized study; Medeniyet University Faculty of Medicine Göztepe Prof. Dr. Forty patients who underwent total knee arthroplasty surgery at Süleyman Yalçın City Hospital were divided into two groups. After the surgery was completed, erector spina plane block was applied to Group E (n=20) patients with 20 ml of 0.25% bupivacaine from the operated side L3-L4 level, while in Group A (n=20) patients, in the area where the sartorius muscle crosses the adductor magnus muscle, it was lateral to the superficial femoral artery. Adductor canal block was applied to the adductor canal with 20 ml of 0.5% bupivacaine. All patients were administered 1 gr paracetamol and 75 mg diclofenac sodium when their pain started in the orthopedic ward. Numerical pain score and quadriceps muscle strength were evaluated during the 48-hour follow-up of the patients. When the pain score was 4 and above, 50 mg pethidine hydrochloride was administered.

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.
40

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

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who underwent total knee arthroplasty surgery
  • ASA I-III patients

Exclusion Criteria:

  • Patients with coagulopathy
  • Patients history with local anesthetic allergy or toxicity
  • Patients with long hospital stay
  • Patients with advanced organ failure
  • Mental retarded patients
  • Presence of infection at the injection site

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: 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.
Active Comparator: Erector Spinae Plane Block
Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
Procedure: Erector Spinae Plane Block
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed parasagittally 2-3 cm lateral to the spinous process at the L3 or L4 level and the transverse process was visualized. The peripheral block needle (85 mm B Braun Stimuplex A) was advanced in plane up to the transverse process and 10 ml 0.5% bupivacaine hydrochloride 10 ml 0.9% isotonic NaCl mixture was applied on the erector spina muscle.
Active Comparator: Adductor Canal Block
Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.
Procedure: Adductor Canal Block
After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed in the middle between the medial condyle and the SIAS, and the superficial femoral artery (FSA) was visualized under the sartorius muscle. By following the FSA distally, the point where the sartorius muscle crosses the adductor magnus muscle, which is the beginning of the adductor canal, was found and the saphenous nerve was visualized hyperechoic in the anterolateral aspect of the FSA. 20 cc 0.5% bupivacaine hydrochloride was applied

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 pain 30 minute
Time Frame: 30. min.
Visual anolog score (1-10)
30. min.
Postoperative pain 1. hour
Time Frame: 1. hour
Visual anolog score (1-10)
1. hour
Postoperative pain 2. hour
Time Frame: 2. hour
Visual anolog score (1-10)
2. hour
Postoperative pain 6. hour
Time Frame: 6. hour
Visual anolog score (1-10)
6. hour
Postoperative pain 12. hour
Time Frame: 12. hour
Visual anolog score (1-10)
12. hour
Postoperative pain 24. hour
Time Frame: 24. hour
Visual anolog score (1-10)
24. hour
Postoperative pain 36. hour
Time Frame: 36. hour
Visual anolog score (1-10)
36. hour
Postoperative pain 48. hour
Time Frame: 48. hour
Visual anolog score (1-10)
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
Opioid consuption 30. min.
Time Frame: 30. min.
Petidine (mg)
30. min.
Opioid consuption 1. hour
Time Frame: 1. hour
Petidine (mg)
1. hour
Opioid consuption 2. hour
Time Frame: 2. hour
Petidine (mg)
2. hour
Opioid consuption 6. hour
Time Frame: 6. hour
Petidine (mg)
6. hour
Opioid consuption 12. hour
Time Frame: 12. hour
Petidine (mg)
12. hour
Opioid consuption 24. hour
Time Frame: 24. hour
Petidine (mg)
24. hour
Opioid consuption 36. hour
Time Frame: 36. hour
Petidine (mg)
36. hour
Opioid consuption 48. hour
Time Frame: 48. hour
Petidine (mg)
48. 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.
Istanbul Medeniyet University

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.
December 15, 2021

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.
June 15, 2022

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 30, 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).
October 6, 2022

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.
November 10, 2022

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.
November 14, 2022

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.
November 14, 2022

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.
November 10, 2022

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.
November 1, 2022

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.
  • IstanbulMUG

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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