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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

48

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

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)

June 7, 2023

Primary Completion (Actual)

November 27, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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