Skip to main content
OpenTrials
Completed

NCT Number: NCT05893771

Depomedrol for Genicular Nerve Block.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University hospitals

Shibīn al Kawm, Menoufia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Depomedrol

Bupivacaine Hcl 0.5% Inj_#2

Drug

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

Other names: Marcaine 0.5%

normal saline

Drug

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

Other names: 0.9% saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. Opioid consumption

    Time frame: 24 hours, 48 hours.

    The amounts of Morphine in milligrams required by each patient will be recorded and compared.

  2. Ambulation distance

    Time frame: Day one, day2 and day3

    The distance in meters that every patient can move without stopping pain.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.