Depomedrol for Genicular Nerve Block.

Postoperative Pain Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05893771
• Other study ID #: 4/2023ANET16
• Status: Completed
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• Bupivacaine Hcl 0.5% Inj_#2
Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline
• normal saline
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.

Locations

Country	Name	City	State
Egypt	Menoufia University hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid consumption	The amounts of Morphine in milligrams required by each patient will be recorded and compared.	24 hours, 48 hours.
Secondary	Ambulation distance	The distance in meters that every patient can move without stopping pain.	Day one, day2 and day3