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Depomedrol for Genicular Nerve Block.

NCT ID: NCT05893771

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2023-11-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be allocated into three equal parallel groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients, caregivers, investigators, and outcome assessors will be blinded by a pharmacist who will prepare medications in colorless coded sterile syringes.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.

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.

Group Type EXPERIMENTAL

Methylprednisolone Injection

Intervention Type DRUG

Ultrasound-guided genicular nerve block comparing Methylprednisolone combined with Bupivacaine to bupivacaine alone. All patients will undergo TKA and will receive spinal anesthesia.

Bupivacaine Hcl 0.5% Inj_#2

Intervention Type DRUG

Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline

normal saline

Intervention Type DRUG

Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hcl 0.5% Inj_#2

Intervention Type DRUG

Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline

normal saline

Intervention Type DRUG

Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.

Interventions

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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.

Intervention Type DRUG

Bupivacaine Hcl 0.5% Inj_#2

Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline

Intervention Type DRUG

normal saline

Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.

Intervention Type DRUG

Other Intervention Names

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Depomedrol Marcaine 0.5% 0.9% saline

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Hazem Ezzat Elsersy

assistant professor of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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4/2023ANET16

Identifier Type: -

Identifier Source: org_study_id