AzTrials
AzTrials

Anterior Cruciate Ligament ReconstructionPhase 4NCT06590402

Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

A Phase 4 study testing Bupivacaine, Dexamethasone in Adductor Canal Block and Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block in people with Anterior Cruciate Ligament Reconstruction and Medial Patellofemoral Ligament Reconstruction, run by Hospital for Special Surgery, New York at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this pilot clinical trial is to compare anterior femoral cutaneous nerve block (AFCN) to adductor canal block ACB) for pediatric patients undergoing either anterior cruciate ligament (ACL) or medial patellofemoral ligament (MPFL). Read more about this study

Who is it for?
Ages 8 to 18 yearsHealthy volunteers can take part
What is being tested?
Bupivacaine, Dexamethasone in Adductor Canal Block and Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
6 Jun 2025to Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 8 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 8-18 years old at the time of surgery
  • Patients 40kg and above
  • ACL reconstruction of MPFL reconstruction surgery with participating surgeons

Who cannot join

  • revision surgery
  • bilateral surgery
  • general anesthesia
  • contraindications to any part of the study protocol
  • relevant pre-existing neurological deficit
  • chronic pain

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marko Popovic contact

646-797-8948

popovicm@hss.edu

Alex Sideris, PhD contact

212-774-2602

Siderisa@hss.edu

United States1 site, 1 recruiting

  • Hospital for Special Surgery

    New York, New York, 10021

    Jashvant Poeran, MD/PhD, poeranj@hss.edu

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries

The goal of this pilot clinical trial is to compare anterior femoral cutaneous nerve block (AFCN) to adductor canal block ACB) for pediatric patients undergoing either anterior cruciate ligament (ACL) or medial patellofemoral ligament (MPFL). The aims of this trial are:

  • To measure postoperative functional outcomes in patients who received AFCNB vs. ACB.
  • To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB.
  • To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB.
  • To quantify sensory deficits in patients who received AFCNB vs. ACB.
  • To assess patient-reported outcome measures (e.g., pain expectation scale, pain management satisfaction, PROMIS Pediatric Short Form v1.0 - Physical Activity, PROMIS Scale v1.2 - Global Health) in patients 8-18 years of age who received AFCNB vs. ACB.
Read more

Subjects undergoing ACL procedures will be compared between those who received the adductor canal block to those who received the anterior femoral cutaneous nerve block. The researchers will also compare individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block with those who received the adductor canal block.

Participants will:

  • Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia.
  • Maintain a patient diary to document daily pain meds/pain scores
  • Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.
Read the detailed description

There is scant literature on the efficacy of peripheral nerve blocks or the comparative effectiveness of anesthesia and analgesia techniques in pediatric/adolescent patients undergoing orthopedic procedures, particularly ambulatory knee procedures such as anterior cruciate ligament (ACL) reconstruction and medial patellofemoral ligament (MPFL) reconstruction. Given the innervation to the knee and concern with residual functional impairment, the goal of our pilot study is to collect preliminary information comparing the anterior femoral cutaneous nerve block (AFCNB) vs adductor canal block (ACB), in the hopes of using this data to power a larger randomized controlled trial to rigorously study this clinical question.

This pilot clinical trial aims to find out what the differences are between anterior femoral cutaneous nerve block (AFCN) and adductor canal block (ACB) for pediatric patients who are having either anterior cruciate ligament (ACL) or medial patellofemoral ligament (MPFL) surgery. There will be 30 subjects in each group/type of surgery. The aims of this trial are:

  • To measure postoperative functional outcomes in patients who received AFCNB vs. ACB.
  • To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB.
  • To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB.
  • To quantify sensory deficits in patients who received AFCNB vs. ACB.
  • To assess patient-reported outcome measures (e.g., pain expectation scale, pain management satisfaction, PROMIS Pediatric Short Form v1.0 - Physical Activity, PROMIS Scale v1.2 - Global Health) in patients 8-18 years of age who received AFCNB vs. ACB. 30 Subjects undergoing ACL procedures will be compared between those who received the adductor canal block (15) to those who received the anterior femoral cutaneous nerve block (15). The researchers will also compare 30 individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block (15) with those who received the adductor canal block (15).

Eligible and enrolled participants will:

  • Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia.
  • Maintain a patient diary to document daily pain meds/pain scores
  • Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.
Being tested
Bupivacaine, Dexamethasone in Adductor Canal Block, Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

What participants receive

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

  • Bupivacaine, Dexamethasone in Adductor Canal BlockDrug

    Also called Adductor Canal Block (ACB)

    0.25% 15-20ml bupivacaine (local anesthestic) delivered as part of the adductor canal block with 2 mg preservative-free dexamethasone (corticosteroid) delivered as part of the adductor canal block

  • Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve BlockDrug

    Also called Anterior Femoral Cutaneous Nerve Block (AFCNB)

    10 ml of 0.25% bupivacaine (local anesthetic) delivered as part of the anterior femoral cutaneous nerve block with 2 mg preservative-free dexamethasone (corticosteroid) delivered as part of the anterior femoral cutaneous nerve block

Study groups in NCT06590402
Study groupRoleWhat they receive
Anterior Cruciate Ligament (ACL) surgeriesExperimentalPediatric subjects who underwent a Anterior Cruciate Ligament (ACL) surgery and are randomized to receive either the adductor canal block (ACB) or the anterior femoral cutaneous nerve block (AFCNB).
Receives: Drug: Bupivacaine, Dexamethasone in Adductor Canal Block; Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Medial Patellofemoral Ligament (MPFL) surgeriesExperimentalPediatric subjects who underwent a Medial Patellofemoral Ligament (MPFL) surgery and are randomized to receive either the adductor canal block (ACB) or the anterior femoral cutaneous nerve block (AFCNB).
Receives: Drug: Bupivacaine, Dexamethasone in Adductor Canal Block; Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

What is being measured

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

  1. Postoperative Function (Motor strength in quadriceps)

    Collected at standard of care postoperative clinical visits with surgeon. Quadriceps strength is measured bilaterally by a handheld dynamometer.

    Measured: 3 months

Secondary outcomes (12)

  1. Cumulative opioid consumption (MMEs)

    Opioids administered to or consumed by patient in the first 48 hours after surgery (starting from "PACU in" time to 48 hours after "PACU in" time)

    Measured: 48 hours after surgery

  2. Total opioid consumption (MMEs)

    defined as cumulative opioid consumption (in MME) from PACU transfer in time to 7 days postoperatively and from PACU transfer in time to 14 days postoperatively

    Measured: at postoperative day 7 & 14

  3. Opioid consumption

    defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively

    Measured: at 6 weeks, 3 months, 6 months

  4. Pain Numerical Rating Scale (NRS) at rest

    Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: preop (baseline); every 30 minutes beginning from PACU transfer in time to discharge; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperatively

  5. Pain Numerical Rating Scale (NRS) with ambulation

    Defined on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

    Measured: preop (baseline); in PACU; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperatively

  6. Postoperative pain location(s)

    Collected at standard of care postoperative clinical visits (2 weeks, 6 weeks, 3 months, 6 months). Will be collected on a knee dermatomal map (with incisions depicted) with location(s) of pain marked and average pain scores at each location

    Measured: at 2 weeks, 6 weeks, 3 months, 6 months

  7. Pain expectation scale

    patient reported on a scale of less, same, or more [or unknown] than expected. With "less" being the lower score and "more" being the higher score.

    Measured: at postoperative days 1, 2, 7, and 14

  8. Satisfaction with pain management

    measured on a scale from 0 to 10, where 0 is very dissatisfied and 10 is very satisfied with the pain management regimen.

    Measured: at postoperative days 1, 2, 7, and 14

  9. postoperative sensation

    collected at standard of care postoperative clinical visits (2 weeks, 6 weeks, 6 months). Will be measured on a knee dermatomal map (with incisions depicted) and classified as "normal," "decreased," or "paresthesia" when compared to the contralateral knee.

    Measured: at 2 weeks, 6 weeks, 3 months, and 6 months

  10. postoperative function - motor strength in quadriceps

    collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer

    Measured: at 2 weeks, 6 weeks, 6 months

  11. postoperative function - range of motion (ROM)

    collected at standard of care postoperative clinical visits with surgeon; range of motion (ROM): measured bilaterally by goniometer

    Measured: at 2 weeks, 6 weeks, 3 months, 6 months

  12. postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.

    collected at standard of care postoperative clinical visits with surgeon; physical function: PROMIS. If the patient is less than 18 years of age, will be assessed using the PROMIS Pediatric Short Form v1.0 - Physical Activity, which contains questions regarding performance of activities such as exercise and play in the past 7 days with 5 answer choices: no days, 1 day, 2-3 days, 4-5 days, and 6-7 days. If the patient is 18 years of age, will be assessed using the PROMIS Scale v1.2 - Global Health, which contains questions regarding physical and mental health rated 1-5, where 1 is worst and 5 is best (physical raw, T, and health scores will be calculated).

    Measured: at 2 weeks, 6 weeks, 3 months, 6 months

Timeline

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

  1. First posted19 Sep 2024
  2. Study start6 Jun 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJan 2028 (estimated)

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
A double-blinded pilot parallel group-randomized trial (GRT), subjects are enrolled and randomized based on their condition, and there is no cross-over of the groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06590402
Sponsor's protocol ID
2024-0582
Status last verified
Oct 2026
First submitted
6 Aug 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.

    PubMed 16301234

  • Wang C, Liu LD, Bai X. Bibliometric and Visual Analysis of the Current Status and Trends of Postoperative Pain in Children from 1950-2021. J Pain Res. 2022 Oct 14;15:3209-3222. doi: 10.2147/JPR.S380842. eCollection 2022.

    PubMed 36267350

  • Micalizzi RA, Williams LA, Pignataro S, Sethna NF, Zurakowski D. Review of outcomes in pediatric patients undergoing anterior cruciate ligament repairs with regional nerve blocks. J Pediatr Nurs. 2014 Nov-Dec;29(6):670-8. doi: 10.1016/j.pedn.2014.07.002. Epub 2014 Jul 13.

    PubMed 25089833

  • Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.

    PubMed 30074928

  • Yee EJ, Gapinski ZA, Ziemba-Davis M, Nielson M, Meneghini RM. Quadriceps Weakness After Single-Shot Adductor Canal Block: A Multivariate Analysis of 1,083 Primary Total Knee Arthroplasties. J Bone Joint Surg Am. 2021 Jan 6;103(1):30-36. doi: 10.2106/JBJS.19.01425.

    PubMed 33079899

  • Zhao XQ, Jiang N, Yuan FF, Wang L, Yu B. The comparison of adductor canal block with femoral nerve block following total knee arthroplasty: a systematic review with meta-analysis. J Anesth. 2016 Oct;30(5):745-54. doi: 10.1007/s00540-016-2194-1. Epub 2016 Jun 4.

    PubMed 27262287

  • Kuang MJ, Ma JX, Fu L, He WW, Zhao J, Ma XL. Is Adductor Canal Block Better Than Femoral Nerve Block in Primary Total Knee Arthroplasty? A GRADE Analysis of the Evidence Through a Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Oct;32(10):3238-3248.e3. doi: 10.1016/j.arth.2017.05.015. Epub 2017 May 17.

    PubMed 28606458

  • Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.

    PubMed 27627711

  • Abdallah FW, Brull R, Joshi GP; Society for Ambulatory Anesthesia (SAMBA). Pain Management for Ambulatory Arthroscopic Anterior Cruciate Ligament Reconstruction: Evidence-Based Recommendations From the Society for Ambulatory Anesthesia. Anesth Analg. 2019 Apr;128(4):631-640. doi: 10.1213/ANE.0000000000003976.

    PubMed 30649069

  • Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.

    PubMed 26938989

  • Christensen JE, Taylor NE, Hetzel SJ, Shepler JA, Scerpella TA. Isokinetic Strength Deficit 6 Months After Adductor Canal Blockade for Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2017 Nov 8;5(11):2325967117736249. doi: 10.1177/2325967117736249. eCollection 2017 Nov.

    PubMed 29152521

  • Frazer AR, Chausse ME, Held M, St-Pierre C, Tsai CY, Preuss R, Descoteaux N, Chan M, Martineau PA, Veilleux LN. Quadriceps and Hamstring Strength in Adolescents 6 Months After ACL Reconstruction With Femoral Nerve Block, Adductor Canal Block, or No Nerve Block. Orthop J Sports Med. 2021 Jul 22;9(7):23259671211017516. doi: 10.1177/23259671211017516. eCollection 2021 Jul.

    PubMed 34368383

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine, Dexamethasone in Adductor Canal Block and Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block in people with Anterior Cruciate Ligament Reconstruction and Medial Patellofemoral Ligament Reconstruction, 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Oct 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Marko Popovic (646-797-8948, popovicm@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Function (Motor strength in quadriceps) (time frame: 3 months). 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 NCT06590402, which also lists 12 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 13 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in