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NCT Number: NCT06590402

Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees

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.

Recruiting

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction Medial Patellofemoral Ligament Reconstruction

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Location status: Recruiting

Location contact

Jashvant Poeran, MD/PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Adductor Canal Block (ACB)

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

Other names: Anterior Femoral Cutaneous Nerve Block (AFCNB)

Primary outcomes

  1. Postoperative Function (Motor strength in quadriceps)

    Time frame: 3 months

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

Secondary outcomes

  1. Cumulative opioid consumption (MMEs)

    Time frame: 48 hours after surgery

    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)

  2. Total opioid consumption (MMEs)

    Time frame: at postoperative day 7 & 14

    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

  3. Opioid consumption

    Time frame: at 6 weeks, 3 months, 6 months

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

  4. Pain Numerical Rating Scale (NRS) at rest

    Time frame: 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

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

  5. Pain Numerical Rating Scale (NRS) with ambulation

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

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

  6. Postoperative pain location(s)

    Time frame: at 2 weeks, 6 weeks, 3 months, 6 months

    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

  7. Pain expectation scale

    Time frame: at postoperative days 1, 2, 7, and 14

    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.

  8. Satisfaction with pain management

    Time frame: at postoperative days 1, 2, 7, and 14

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

  9. postoperative sensation

    Time frame: at 2 weeks, 6 weeks, 3 months, and 6 months

    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.

  10. postoperative function - motor strength in quadriceps

    Time frame: at 2 weeks, 6 weeks, 6 months

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

  11. postoperative function - range of motion (ROM)

    Time frame: at 2 weeks, 6 weeks, 3 months, 6 months

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

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

    Time frame: at 2 weeks, 6 weeks, 3 months, 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Sideris, PhD

CONTACT

[email protected]

212-774-2602

Marko Popovic

CONTACT

[email protected]

646-797-8948

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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