Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-12 @ 12:22 AM
Study NCT ID:
NCT06590402
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Sponsor:
Hospital for Special Surgery, New York
Organization:
Study Overview
Official Title:
A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: