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ACLPhase 4NCT05720949

Genicular Nerve Blocks for Anterior Cruciate Ligament Knee Surgery

A Phase 4 study testing Genicular Nerve Block with bupivacaine and preservative free dexamethasone in people with ACL and Anterior Cruciate Ligament Injuries, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this randomized controlled trial is to assess a new analgesia regimen that includes the addition of genicular never blocks to our current standard regimen of peripheral nerve blocks, which includes an adductor canal block (ACB) and interspace between the popliteal artery and capsule of the posterior… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
ACL, Anterior Cruciate Ligament Injuries
What is being tested?
Genicular Nerve Block with bupivacaine and preservative free dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
12 Jan 2023to 2 Dec 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 80
  • English speaking
  • American Society of Anesthesiologists (ASA) I - III
  • BMI < 35
  • Scheduled for ambulatory arthroscopic unilateral anterior cruciate ligament repair surgery with bone tendon bone autograft

Who cannot join

  • History of chronic pain syndromes
  • Chronic opioid use (daily morphine milligram equivalents > 30 mg for at least 3 months)
  • Contraindication to peripheral nerve blocks
  • Contraindication to neuraxial anesthesia
  • History of peripheral neuropathy or pre-existing neurological deficits
  • Psychiatric or cognitive disorder that prohibit patient from following study protocol
Show all 11Show fewer
  • Allergy to local anesthetic or study medications
  • Multi-ligament surgery
  • History of substance abuse
  • Infection at the site of injection
  • diagnoses of Type I or Type II diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site
  • HSS Sports Medicine Institute West Side

    New York, New York, 10019

Other trials in United States

About this study

Official title: Genicular Nerve Blocks for Arthroscopic Anterior Cruciate Knee Surgery: a Randomized Controlled Trial

The purpose of this randomized controlled trial is to assess a new analgesia regimen that includes the addition of genicular never blocks to our current standard regimen of peripheral nerve blocks, which includes an adductor canal block (ACB) and interspace between the popliteal artery and capsule of the posterior knee block (IPACK). The main questions it aims to answer are:

  1. Does addition of genicular nerve blocks to standard peripheral block regimen significantly reduce the mean opioid consumption by 33% in the first 24 hours?
  2. Does genicular nerve blocks reduce NRS pain scores?
  3. Does genicular nerve blocks facilitate earlier discharge?
  4. Does genicular nerve blocks last longer than 24 hours?
  5. Does genicular nerve blocks improve pain management?

Eligible patients are those undergoing an anterior cruciate ligament repair at the Hospital for Special Surgery and participants will be randomized to receive the intervention (genicular nerve block) or the standard of care.

Read the detailed description

Genicular nerve blocks have been shown to provide effective analgesia for chronic osteoarthritis knee pain. There are several publications supporting its use for chronic knee pain but there is a scarcity of literature in its use in the perioperative period. Recently, it has been shown to provide effective analgesia for total knee arthroplasty. This will be a novel application for it to be used for anterior cruciate ligament surgery. There are only a couple of prospective and retrospective studies that showed promising analgesic benefits for anterior cruciate ligament repairs. There are currently no randomized controlled trials published investigating the use of genicular nerve blocks for anterior cruciate ligament surgery.

Researching novel innovative motor-sparing and opioid-sparing peripheral nerve blocks for have been the focus of research. Studies have investigated the motor sparing benefits of the adductor canal block, the effective analgesic benefits of the IPACK block, the phrenic sparing benefits of the superior trunk block, and the analgesic benefits of the pericapsular nerve group block and lateral femoral cutaneous nerve. Genicular nerve blocks would be a potential additive block that may further enhance the recovery of patients undergoing knee surgeries, including unicondylar, total knee and anterior cruciate ligament repair patients.

Being tested
Genicular Nerve Block with bupivacaine and preservative free dexamethasone
Keywords
ACL, Genicular nerve block, Anterior Cruciate Ligament Injuries, Opioid Consumption
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genicular Nerve Block with bupivacaine and preservative free dexamethasoneDrug

    Also called Exparel, Ozurdex

    A genicular nerve block is a peripheral nerve block that temporarily anesthetizes the sensory terminal branches innervating the knee joint by injecting local anesthesia. This results in anesthesia of the anterior compartment of the knee.

    The genicular nerve block consists of 20cc of 0.25% bupivacaine with 2mg of preservative free dexamethasone and will be applied to the superomedial genicular nerve, superolateral genicular nerve, inferomedial genicular nerve, and nerve to vastus intermedius.

    Bupivacaine - Drug class: Sodium channel blocker

    Dexamethasone - Drug class: Glucocorticoid

Study groups in NCT05720949
Study groupRoleWhat they receive
Group 1 - ControlNo interventionPatients 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.
Group 2 - InterventionExperimentalPatients 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.
Receives: Drug: Genicular Nerve Block with bupivacaine and preservative free dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Opioid Consumption at 24 Hours

    Intravenous and Oral opioid consumption at 24 hours after recovery room entry will be recorded.

    The average consumption will be reported in morphine milligram equivalents.

    Measured: Post-operative care unit (PACU) arrival time to 24 hours

Secondary outcomes (10)
  1. Opioid Consumption

    Opioid consumption up to 168 hours after surgery will be recorded from the medical record and patient reported phone calls

    Opioid consumption in morphine milligram equivalents will be calculated and reported for each time point.

    Measured: PACU(PACU arrival time to removal from board), 48,72,96,168 hours after time zero (PACU arrival time)

  2. Numeric Rating Scale (NRS) Pain Scores

    Patient scores at rest and with movement will be recorded. Scale of 0 to 10, with 0 meaning "no pain" and 10 meaning "worst pain imaginable". Lower score means less pain, higher score means greater pain.

    Measured: PACU (60 minutes after PACU arrival time), 24,48,72,96,168 hours after time zero (PACU arrival time)

  3. Cumulative Opioid Consumption

    Total opioid consumption will be recorded up to 96 hours after surgery.

    Measured: sum of opioid used from 0-24 hours, 0-48 hours, and 0-72 hours, 0-96 hours post-operatively

  4. Brief Pain Inventory

    This questionnaire will assess severity of pain, impact of pain on daily function, location of pain, medication intake, and amount of pain relief preoperatively and at 24 hours, 48 hours, 72 hours, 96 hours, and 168 hours after surgery.

    Questions are rated on a scale of 0 to 10, with 0 meaning "no pain/interference" and 10 meaning "pain as bad as you can imagine/completely interferes".

    Measured: Pre-operatively, 24 hours, 48 hours, 72 hours, 96 hours, 168 hours post-operative

  5. Patient Satisfaction With Pain Treatment

    Patient satisfaction will be assessed in the post-operative care unit (PACU), 24 hours, and 48 hours after surgery.

    Patients reported satisfaction for 3 subcategories: 1) Satisfaction with Pain Management, 2) Satisfaction with Being Informed and Involved with Decision Making, 3) Satisfaction with Care from Healthcare Team. Each subcategory had a scale of 0-10, with 0 being strongly dissatisfied and 10 being strongly satisfied.

    Measured: From the time patient arrived in the post-operative care unit (PACU), at 24 hours, and at 48 hours post-operative

  6. Duration of Analgesic Block

    To assess when the patient believe the analgesic block wore off and they regain sensation in their leg.

    Measured: 24 hours and 48 hours post-operative

  7. Success of Adductor Canal Block

    Numbness in the saphenous distribution will be assessed in the PACU by an anesthesiologist or research assistant. This was measured on scale of 0-2, with 0 being no sensation, 1 being partial sensation, and 2 being full sensation.

    Measured: Post-operative care unit (PACU)

  8. Readiness for PACU Discharge

    The duration from PACU arrival time to recovery complete time.

    The time that it took for the patient to be discharged will be calculated and reported.

    Measured: From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time the patient is discharged(discharge ready time = recovery complete time) assessed up to 24 hours after surgery.

  9. Length of PACU Stay

    The duration from PACU arrival time to patient removed from board time.

    The time (in minutes) will be calculated and reported.

    Measured: From the time the patient arrived in the post-operative care unit (PACU) arrival time to the time they leave the PACU assessed up to 24 hours after surgery.

  10. Adverse Events

    Incidence of neuropraxia (neurological symptoms over 3 days), local anesthetic systemic toxicity (LAST), and infection.

    The number of adverse events will be reported.

    Measured: Post-operative care unit (PACU) arrival time up to 72 hours after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start12 Jan 2023
  3. Primary completion26 Nov 2024
  4. Study completion2 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind randomized control trail
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720949
Sponsor's protocol ID
2022-1962
Status last verified
Dec 2024
First submitted
18 Jan 2023
Last updated
26 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual patient data with other researchers.

Publications

  • Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.

    PubMed 34308957
  • Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.

    PubMed 34261807
  • Caldwell GL Jr, Selepec MA. Reduced Opioid Use After Surgeon-Administered Genicular Nerve Block for Anterior Cruciate Ligament Reconstruction in Adults and Adolescents. HSS J. 2019 Feb;15(1):42-50. doi: 10.1007/s11420-018-09665-9. Epub 2019 Jan 28.

    PubMed 30863232
  • Gruskay JA, Pearce SS, Ruttum D, Conrad ES 3rd, Hackett TR. Surgeon-Administered Anterolateral Geniculate Nerve Block as an Adjunct to Regional Anesthetic for Pain Management Following Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2022 Jan 20;11(1):e1-e6. doi: 10.1016/j.eats.2021.08.034. eCollection 2022 Jan.

    PubMed 35127422
  • Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

    PubMed 24401769
  • Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.

    PubMed 30234517
  • Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.

    PubMed 31283740

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Genicular Nerve Block with bupivacaine and preservative free dexamethasone in people with ACL and Anterior Cruciate Ligament Injuries, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Opioid Consumption at 24 Hours (time frame: Post-operative care unit (PACU) arrival time to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05720949, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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