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Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status and phase

Enrolling
Phase 4

Conditions

Medial Patellofemoral Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06590402
2024-0582

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

8 to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Anterior Cruciate Ligament (ACL) surgeries
Experimental group
Description:
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).
Treatment:
Drug: Bupivacaine, Dexamethasone in Adductor Canal Block
Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Medial Patellofemoral Ligament (MPFL) surgeries
Experimental group
Description:
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).
Treatment:
Drug: Bupivacaine, Dexamethasone in Adductor Canal Block
Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Alex Sideris, PhD; Marko Popovic

Data sourced from clinicaltrials.gov

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