Depomedrol for Genicular Nerve Block.

NCT05893771 | Completed

• 1 other identifier: 4/2023ANET16
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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 Outcomes (2)

• Opioid consumption

  24 hours, 48 hours.

• Ambulation distance

  Day one, day2 and day3

Study Arms (3)

Placebo control

PLACEBO COMPARATOR

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

Depomedrol group

EXPERIMENTAL

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: Methylprednisolone Injection; Drug: Bupivacaine Hcl 0.5% Inj_#2; Drug: normal saline

Bupivacaine group

ACTIVE COMPARATOR

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: Bupivacaine Hcl 0.5% Inj_#2; Drug: normal saline

Interventions

Methylprednisolone Injection DRUG

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

Also known as: Depomedrol

Depomedrol group

Bupivacaine Hcl 0.5% Inj_#2 DRUG

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

Also known as: Marcaine 0.5%

Bupivacaine group; Depomedrol group

normal saline DRUG

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

Also known as: 0.9% saline

Bupivacaine group; Depomedrol group; Placebo control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospitals

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methylprednisolone; Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, caregivers, investigators, and outcome assessors will be blinded by a pharmacist who will prepare medications in colorless coded sterile syringes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Model Details: Patients will be allocated into three equal parallel groups.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 8, 2023
• Study Start: June 7, 2023
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After 6 months from publication date and for 5 years

Locations

EG (1)