Depomedrol for Genicular Nerve Block.

November 28, 2023 updated by: Hazem Ezzat Elsersy, Menoufia University

Evaluation of the Feasibility of Depomedrol Added to Bupivacaine in Ultrasound-guided Genicular Nerve Block in the Combination With Adductor Canal Block for Postoperative Analgesia and Rehabilitation After Reconstructive Knee Surgery.

This study is designed to test the efficacy of adding Depomedrol a long-acting steroid to bupivacaine for relieving postoperative pain and reducing opioid requirements following total knee replacement surgery. For this purpose, Depomedrol will be added to bupivacaine for ultrasound-guided Genicular nerve block combined 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

TKA remains a challenge for physicians as more than half of these patients experience extreme knee pain immediately after surgery. The management of pain in patients undergoing total knee arthroplasty (TKA) remains a challenge for the anesthesiologist even with regional anesthesia as no single regional technique is adequate to balance effective analgesia with minimal muscle weakness. Severe postoperative pain following TKA has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-op recovery. Multimodal analgesia incorporating regional anesthesia techniques provides optimum analgesia and minimizes the use of opioids and their side effects. Proximal nerve blocks such as the lumbar plexus, femoral nerve, and proximal sciatic nerve blocks provide excellent analgesia but frequently cause motor weakness, which reduces the patient's mobility. A distal blockade of genicular branches has also been described using ultrasound in acute and chronic pain management with fewer side effects. The superior medial genicular nerve and lateral genicular nerve can be identified using ultrasound and blocked at the level of the medial intramuscular, and lateral femoral epicondyles deep to the vastus medialis and lateralis, respectively. The inferior medial genicular nerve can be also targeted medial to the tibial plateau adjacent to the genicular vessels. Methylprednisolone acetate (MPA)(Depomedrol) is a lipophilic glucocorticoid commonly used in chronic pain procedures. It has a good safety record and its analgesic action can last from days to weeks.(8) The literature supporting its role as an adjuvant to local anesthetic in peripheral nerve block are scanty. However, some studies showed that depo-methylprednisolone as an adjuvant to 0.5% lidocaine showed excellent results in neuropathic pain resulting from nerve injury. This study aims to evaluate the efficacy of adding depomedrol as an additive to bupivacaine in genicular nerve block for evaluating postoperative pain, opioid use, and ease of ambulation in patients undergoing TKA.

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.
48

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 Contact Backup

Study Locations

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt
        • Menoufia University Hospitals

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:

  • Subjects scheduled for primary elective total knee arthroplasty.
  • American Society of Anesthesiologists Physical Status I-III.
  • BMI 18-35 kg/m2.

Exclusion Criteria:

  • Bleeding disorders.
  • Allergy to any of the drugs used in the study.
  • Renal insufficiency.
  • Liver failure
  • Neurological abnormalities (uncooperative or psychologically unstable patients).
  • Patient refusal.
  • Contraindication to a peripheral nerve block.
  • ASA IV or V.
  • Skin lesions/infection at block 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: Quadruple

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.
Placebo Comparator: Placebo control
With ultrasound guidance, 20 ml plain normal saline will be injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee after arrival to the theatre.
Drug: normal saline
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.
Other Names:
  • 0.9% saline
Experimental: Depomedrol group
With ultrasound guidance, a mixture of 5 ml Bupivacaine 0.5%, 1 ml (20 mg) depomedrol, and 14 ml normal saline is injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee after arrival at the theatre.
Drug: normal saline
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.
Other Names:
  • 0.9% saline
Drug: Methylprednisolone Injection
Ultrasound-guided genicular nerve block comparing Methylprednisolone combined with Bupivacaine to bupivacaine alone. All patients will undergo TKA and will receive spinal anesthesia.
Other Names:
  • Depomedrol
Drug: Bupivacaine Hcl 0.5% Inj_#2
Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline
Other Names:
  • Marcaine 0.5%
Active Comparator: Bupivacaine group
A mixture of 5 ml Bupivacaine 0.5%- and 14-ml normal saline is injected to spread lateral to the femoral artery and deep to the sartorius muscle, or more distal, below the knee, after arrival at the theatre.
Drug: normal saline
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.
Other Names:
  • 0.9% saline
Drug: Bupivacaine Hcl 0.5% Inj_#2
Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline
Other Names:
  • Marcaine 0.5%

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
Time Frame: 48 hours.
will be assessed postoperatively using 10 points numerical rating scale (NRS) where 0 no pain and 10 is the most intense pain. The median of pain scores through 48 hours will be compared.
48 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
Opioid consumption
Time Frame: 24 hours, 48 hours.
The amounts of Morphine in milligrams required by each patient will be recorded and compared.
24 hours, 48 hours.
Ambulation distance
Time Frame: Day one, day2 and day3
The distance in meters that every patient can move without stopping pain.
Day one, day2 and day3

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.
Menoufia 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.
June 7, 2023

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.
November 27, 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.
November 27, 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).
May 16, 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.
May 29, 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.
June 8, 2023

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 29, 2023

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 28, 2023

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, 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.
  • 4/2023ANET16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all of the individual participant data collected during the trial after deidentification.

IPD Sharing Time Frame

After 6 months from publication date and for 5 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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