Depomedrol for Genicular Nerve Block.

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05893771

Collaborator

(none)

Enrollment

Location

Arms

4.8

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Methylprednisolone Injection Drug: Bupivacaine Hcl 0.5% Inj_#2 Drug: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be allocated into three equal parallel groups.Patients will be allocated into three equal parallel groups.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Jun 7, 2023

Anticipated Primary Completion Date :

Oct 2, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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: 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% Drug: normal saline Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control. Other Names: 0.9% saline
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: 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% Drug: normal saline Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control. Other Names: 0.9% saline

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: 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%

Drug: normal saline

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

Other Names:

0.9% saline

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: 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%

Drug: normal saline

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

Other Names:

0.9% saline

Outcome Measures

Primary Outcome Measures

Postoperative pain [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 Outcome Measures

Opioid consumption [24 hours, 48 hours.]
The amounts of Morphine in milligrams required by each patient will be recorded and compared.
Ambulation distance [Day one, day2 and day3]
The distance in meters that every patient can move without stopping pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.