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Genicular Nerve Block for ACL Surgery

Phase 4

Recruiting

Led By David H Kim, MD

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 sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

Awards & highlights

Study Summary

This trial tests if adding genicular nerve blocks to a standard peripheral block regimen can reduce opioid use, pain scores, and improve discharge times for ACL surgery patients.

Who is the study for?

This trial is for adults aged 18-80 with a BMI under 35, scheduled for ACL knee surgery using their own tissue grafts. They must speak English and have an ASA classification of I-III, indicating they're healthy or have mild to moderate systemic disease. People can't join if they use opioids daily, have chronic pain syndromes, substance abuse history, allergies to local anesthetics or study drugs, psychiatric conditions affecting protocol adherence, infection at the injection site, or certain nerve issues.Check my eligibility

What is being tested?

The trial tests whether adding genicular nerve blocks to standard peripheral nerve blocks reduces opioid use by one-third in the first day after ACL surgery. It also examines if this method lowers pain scores, speeds up discharge times from the hospital, provides over 24 hours of relief and improves overall pain management post-surgery.See study design

What are the potential side effects?

Potential side effects may include discomfort at the injection site, allergic reactions to bupivacaine or dexamethasone used in genicular nerve blocks. There's also a risk of temporary numbness or weakness in the leg due to nerve blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours, and 0-168 hours post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Opioid Consumption at 24 hours

Secondary outcome measures

Adverse events

Brief Pain Inventory

Cumulative opioid pills consumption

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2 - InterventionExperimental Treatment1 Intervention

Patients randomized to this group will receive an adductor canal block (ACB), Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block, and the genicular nerve block (intervention). The genicular nerve block is a total of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.

Group II: Group 1 - ControlActive Control1 Intervention

Patients randomized to this group will receive an adductor canal block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) nerve block.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,138 Total Patients Enrolled

3 Trials studying Anterior Cruciate Ligament Injury

136 Patients Enrolled for Anterior Cruciate Ligament Injury

Justas Lauzadis, PhDStudy DirectorHospital for Special Surgery, Department of Anesthesiology

2 Previous Clinical Trials

64 Total Patients Enrolled

David H Kim, MDPrincipal InvestigatorHospital for Special Surgery, Department of Anesthesiology

5 Previous Clinical Trials

617 Total Patients Enrolled

Media Library

Anterior Cruciate Ligament Injury Research Study Groups: Group 1 - Control, Group 2 - Intervention

Frequently Asked Questions

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

Are septuagenarians welcomed as participants in this research?

"This trial has a strict age limit, with the youngest permitted participant being 18 years old and the oldest capped at 80."

Answered by AI

Is it possible for me to participate in the current clinical experiment?

"To partake in this experiment, the subject must have suffered an ACL lesion and be between 18-80 years old. Altogether, 192 volunteers are being sought."

Answered by AI

Has the Intervention protocol within Group 2 obtained FDA authorization?

"The safety of Group 2 - Intervention is rated a 3 due to it being a Phase 4 trial, suggesting that this treatment has been approved by regulatory authorities."

Answered by AI

Are there still opportunities to join this research trial?

"Based on the information provided by clinicaltrials.gov, this research is actively recruiting participants at present. The initial post date was December 1st 2023, with a recent update made February 6th of that same year."

Answered by AI

To what extent is enrollment still occurring for this medical trial?

"Affirmative. As evidenced on clinicaltrials.gov, this medical trial is currently seeking participants. It was initially posted on December 1st 2023 and most recently updated February 6th of the same year. This research requires 192 individuals from one location to participate."

Answered by AI

Recent research and studies

versusJournal

Adductor Canal Block<i>versus</i>femoral Nerve Block for Total Knee Arthroplasty

Kim, David H., Yi Lin, Enrique A. Goytizolo, Richard L. Kahn, Daniel B. Maalouf, Asha Manohar, Minda L. Patt, et al.. 2014. “Adductor Canal Blockversusfemoral Nerve Block for Total Knee Arthroplasty”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000000119.

clinicaltrials.govStudy

Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

David Kim 2023. "Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05720949.