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Procedure
Nerve Blocks for Knee Replacement Surgery
Phase 4
Recruiting
Led By Jiabin Liu, MD/PhD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery
Awards & highlights
Summary
This trial is testing if adding two specific nerve blocks to the usual pain management can better control pain and reduce the need for opioids in patients having knee replacement surgery. The study aims to see if this approach helps with pain relief and quicker recovery.
Who is the study for?
This trial is for adults aged 18-80 undergoing knee replacement surgery without chronic opioid use, severe kidney disease, allergies to local anesthetics or study drugs, neurological deficits, or certain other health issues. They must have a BMI under 35 and not be on anticonvulsants.
What is being tested?
The study tests if adding genicular and anterior femoral cutaneous nerve blocks to standard care reduces pain and opioid use after knee surgery. Participants are randomly assigned to receive these nerve blocks or not as part of their post-surgery care.
What are the potential side effects?
Possible side effects from the injections include pain at the injection site, infection risk, allergic reactions to the medications used (Fentanyl, Mepivacaine), and potential impacts on nerve function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in the post-operative care unit (pacu) up to 24 hours after surgery end
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in the post-operative care unit (pacu) up to 24 hours after surgery end
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Numerical Rating Scale (NRS) pain score
Secondary study objectives
Bang Blinding Index
Brief Pain Inventory (short form)
Cumulative opioid consumption
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 Genicular TKAExperimental Treatment4 Interventions
The genicular group will receive the study intervention of a genicular nerve block and anterior femoral cutaneous nerve block. The intervention group (genicular nerve block/anterior femoral cutaneous nerve block) will receive additional nerve blocks totaling 30 ml of 0.25% bupivacaine with 4 mg preservative-free dexamethasone (5 ml for each block: SMGN, IMGN, SLGN, NVI; 10ml for AFCN).
The genicular group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) and the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).
Group II: Group 1 Standard TKAActive Control1 Intervention
The standard TKA group will receive the standard of care analgesia. Those in the control group will be given 7 mg of the preservative dexamethasone intravenously.
The standard group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) as well as the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fentanyl
2019
Completed Phase 4
~1920
Mepivacaine
2013
Completed Phase 4
~23710
Bupivacaine Injection
2017
Completed Phase 4
~580
Dexamethasone injection
2019
Completed Phase 4
~390
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Total Knee Arthroplasty (TKA) include general anesthesia, neuraxial anesthesia, and localized nerve blocks such as genicular nerve block and anterior femoral cutaneous nerve block. General anesthesia induces a reversible loss of consciousness, while neuraxial anesthesia (e.g., spinal or epidural) blocks nerve signal transmission in the lower body, reducing pain and improving postoperative outcomes.
Localized nerve blocks, like the genicular and anterior femoral cutaneous nerve blocks, work by interrupting nerve signal transmission at specific sites, providing targeted pain relief and potentially reducing the need for systemic opioids. Understanding these mechanisms is crucial for TKA patients as it helps in selecting the most appropriate pain management strategy, minimizing side effects, and enhancing recovery.
Find a Location
Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,145 Total Patients Enrolled
Jiabin Liu, MD/PhDPrincipal InvestigatorHospital for Special Surgery, New York
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have spinal or epidural anesthesia.I have a long-term pain condition.I have been using opioids daily for pain for over 3 months.I am allergic to certain anesthetics or medications used in this study.I have had surgery to repair multiple ligaments.I am between 18 and 80 years old.I am having or had a knee replacement surgery and stayed less than 24 hours.I have a history of nerve damage or existing nerve issues.I have an infection where I received an injection.I am currently on medication for seizures.I have chronic kidney disease.I cannot have nerve block procedures due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 Standard TKA
- Group 2: Group 2 Genicular TKA
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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