Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

NCT06590402 | Recruiting Phase 4

• 1 other identifier: 2024-0582
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Anterior Cruciate Ligament Reconstruction; Medial Patellofemoral Ligament Reconstruction

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (12)

• Cumulative opioid consumption (MMEs)

  48 hours after surgery

• Total opioid consumption (MMEs)

  at postoperative day 7 & 14

• Opioid consumption

  at 6 weeks, 3 months, 6 months

• Pain Numerical Rating Scale (NRS) at rest

  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

• Pain Numerical Rating Scale (NRS) with ambulation

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

Study Arms (2)

Anterior Cruciate Ligament (ACL) surgeries

EXPERIMENTAL

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).

Drug: Bupivacaine, Dexamethasone in Adductor Canal Block; Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

Medial Patellofemoral Ligament (MPFL) surgeries

EXPERIMENTAL

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).

Drug: Bupivacaine, Dexamethasone in Adductor Canal Block; Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

Interventions

Bupivacaine, Dexamethasone in Adductor Canal Block 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

Also known as: Adductor Canal Block (ACB)

Anterior Cruciate Ligament (ACL) surgeries; Medial Patellofemoral Ligament (MPFL) surgeries

Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block 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

Also known as: Anterior Femoral Cutaneous Nerve Block (AFCNB)

Anterior Cruciate Ligament (ACL) surgeries; Medial Patellofemoral Ligament (MPFL) surgeries

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 16301234 BACKGROUND

• 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.

  PMID: 36267350 BACKGROUND

• 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.

  PMID: 25089833 BACKGROUND

• 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.

  PMID: 30074928 BACKGROUND

• 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.

  PMID: 33079899 BACKGROUND

• 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.

  PMID: 27262287 BACKGROUND

• 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.

  PMID: 28606458 BACKGROUND

• 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.

  PMID: 27627711 BACKGROUND

• 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.

  PMID: 30649069 BACKGROUND

• 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.

  PMID: 26938989 BACKGROUND

• 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.

  PMID: 29152521 BACKGROUND

• 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.

  PMID: 34368383 BACKGROUND

Related Links

• Anterior Femoral Cutaneous Nerve Block (Dr. Jeff Gadsden)
• Anterior Femoral Cutaneous Nerve Block (Dr. Amit Pawa)

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Kathryn DelPizzo, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marko Popovic

CONTACT

646-797-8948; popovicm@hss.edu

Alex Sideris, PhD

CONTACT

212-774-2602; Siderisa@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 19, 2024
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)