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Depomedrol for Genicular Nerve Block.

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Methylprednisolone Injection
Bupivacaine Hcl 0.5% Inj_#2
normal saline
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Menoufia University hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo control

Depomedrol group

Bupivacaine group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Opioid consumption
The amounts of Morphine in milligrams required by each patient will be recorded and compared.
Ambulation distance
The distance in meters that every patient can move without stopping pain.

Full Information

First Posted
May 16, 2023
Last Updated
June 7, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT05893771
Brief Title
Depomedrol for Genicular Nerve Block.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be allocated into three equal parallel groups.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients, caregivers, investigators, and outcome assessors will be blinded by a pharmacist who will prepare medications in colorless coded sterile syringes.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Depomedrol group
Arm Type
Experimental
Arm Description
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.
Arm Title
Bupivacaine group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Other Intervention Name(s)
Depomedrol
Intervention Description
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
Intervention Name(s)
Bupivacaine Hcl 0.5% Inj_#2
Other Intervention Name(s)
Marcaine 0.5%
Intervention Description
Ultasound- guided genicular nerve block using 5 ml bupivacaine 0.5% in 15 ml saline
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
0.9% saline
Intervention Description
Ultrasound guided genicular nerve infiltration with 20 ml normal saline as a placebo control.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
48 hours.
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
The amounts of Morphine in milligrams required by each patient will be recorded and compared.
Time Frame
24 hours, 48 hours.
Title
Ambulation distance
Description
The distance in meters that every patient can move without stopping pain.
Time Frame
Day one, day2 and day3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hazem E Elsersy, MD
Phone
+201091096655
Email
hazelsersy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hala Koptan, MD
Phone
+201227305322
Email
halakoptan@yahoo.com
Facility Information:
Facility Name
Menoufia University hospitals
City
Shibīn Al Kawm
State/Province
Menoufia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hazem E Elsersy, MD
Phone
+201091096655
Email
hazelsersy@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all of the individual participant data collected during the trial after deidentification.
IPD Sharing Time Frame
After 6 months from publication date and for 5 years

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Depomedrol for Genicular Nerve Block.

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