Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

NCT ID: NCT06590402

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-06

Study Completion Date

2028-01-31

Brief Summary

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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.

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.

Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Reconstruction Medial Patellofemoral Ligament Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Blinding of the patient/parent or guardian and research staff collecting data will be maintained via the "SNOSE" technique (Sequentially Numbered Opaque Sealed Envelope), whereby prior to study start, a research staff member not otherwise involved in the study will prepare envelopes with the randomization written on the card and secured in the envelopes, and the study ID number written outside the envelope.

Study Groups

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Anterior Cruciate Ligament (ACL) surgeries

Pediatric 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).

Group Type EXPERIMENTAL

Bupivacaine, Dexamethasone in Adductor Canal Block

Intervention Type DRUG

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 Block

Intervention Type DRUG

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

Medial Patellofemoral Ligament (MPFL) surgeries

Pediatric 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).

Group Type EXPERIMENTAL

Bupivacaine, Dexamethasone in Adductor Canal Block

Intervention Type DRUG

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 Block

Intervention Type DRUG

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

Interventions

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Bupivacaine, Dexamethasone in Adductor Canal Block

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

Intervention Type DRUG

Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

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

Intervention Type DRUG

Other Intervention Names

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Adductor Canal Block (ACB) Anterior Femoral Cutaneous Nerve Block (AFCNB)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathryn DelPizzo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marko Popovic

Role: CONTACT

646-797-8948

Alex Sideris, PhD

Role: CONTACT

212-774-2602

Facility Contacts

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Jashvant Poeran, MD/PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 16301234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36267350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25089833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30074928 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33079899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27262287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28606458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27627711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30649069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26938989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29152521 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34368383 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.youtube.com/watch?v=zzj08axeE94

Anterior Femoral Cutaneous Nerve Block (Dr. Jeff Gadsden)

http://www.youtube.com/watch?v=bAxMvcTf0kU

Anterior Femoral Cutaneous Nerve Block (Dr. Amit Pawa)

Other Identifiers

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2024-0582

Identifier Type: -

Identifier Source: org_study_id

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