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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

Study Summary

This trial will investigate if nerve blocks can reduce pain and opioid consumption after knee replacement surgery.

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.Check my eligibility
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.See study design
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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and in the post-operative care unit (pacu), up to 24 hours after surgery end and at 7 days after the day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Bang Blinding Index
Brief Pain Inventory (short form)
Cumulative opioid consumption
+3 more

Trial 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
~1870
Mepivacaine
2013
Completed Phase 4
~23660
Bupivacaine Injection
2017
Completed Phase 4
~580
Dexamethasone injection
2019
Completed Phase 4
~260

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,086 Total Patients Enrolled
Jiabin Liu, MD/PhDPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

Genicular and Anterior Femoral Cutaneous Nerve Blocks (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05980546 — Phase 4
Total Knee Arthroplasty Research Study Groups: Group 1 Standard TKA, Group 2 Genicular TKA
Total Knee Arthroplasty Clinical Trial 2023: Genicular and Anterior Femoral Cutaneous Nerve Blocks Highlights & Side Effects. Trial Name: NCT05980546 — Phase 4
Genicular and Anterior Femoral Cutaneous Nerve Blocks (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05980546 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the qualifications to enroll in this trial?

"Eligibility for this clinical trial is limited to those aged between 18 and 80 who have undergone a total knee arthroplasty. At present, 244 participants are being recruited."

Answered by AI

Is this trial currently admitting suitable participants?

"As indicated on clinicaltrials.gov, this medical trial is actively recruiting potential participants with June 7th 2021 as the initial post date and July 31st 2023 being the last edit to its information."

Answered by AI

Does this research endeavor restrict eligibility to those under 80 years of age?

"According to the specifications, this study is open for anyone aged 18 and above up until 80 years old. For those younger than 18 or older than 65, there are separate trials that can be looked into - with 18 options available for minors and 132 possibilities for seniors."

Answered by AI

To what extent is participation in this trial being sought out?

"Affirmative. According to information found on clinicaltrials.gov, the medical trial is currently in search of applicants; it was first posted on June 7th 2023 and revised most recently on July 31st 2023. This study needs 244 patients from one centre to participate."

Answered by AI

Has the FDA greenlighted Group 2 Genicular TKA?

"Group 2 Genicular TKA is an approved medical intervention, so it's safety rating on our 1-3 scale was 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty
2023. "Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05980546.
~127 spots leftby May 2025
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