A Phase 4 interventional study of Bupivacaine, Dexamethasone in Adductor Canal Block and Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block in Anterior Cruciate Ligament Reconstruction and Medial Patellofemoral Ligament Reconstruction, sponsored by Hospital for Special Surgery, New York. Recruiting at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Other
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:
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:
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 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:
Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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)
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)
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.
Time frame: 3 months
Cumulative opioid consumption (MMEs)
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)
Time frame: 48 hours after surgery
Total opioid consumption (MMEs)
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
Time frame: at postoperative day 7 & 14
Opioid consumption
defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively
Time frame: at 6 weeks, 3 months, 6 months
Pain Numerical Rating Scale (NRS) at rest
Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
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
Pain Numerical Rating Scale (NRS) with ambulation
Defined on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Time frame: preop (baseline); in PACU; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperatively
Postoperative pain location(s)
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
Time frame: at 2 weeks, 6 weeks, 3 months, 6 months
Pain expectation scale
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.
Time frame: at postoperative days 1, 2, 7, and 14
Satisfaction with pain management
measured on a scale from 0 to 10, where 0 is very dissatisfied and 10 is very satisfied with the pain management regimen.
Time frame: at postoperative days 1, 2, 7, and 14
postoperative sensation
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.
Time frame: at 2 weeks, 6 weeks, 3 months, and 6 months
postoperative function - motor strength in quadriceps
collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer
Time frame: at 2 weeks, 6 weeks, 6 months
postoperative function - range of motion (ROM)
collected at standard of care postoperative clinical visits with surgeon; range of motion (ROM): measured bilaterally by goniometer
Time frame: at 2 weeks, 6 weeks, 3 months, 6 months
postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.
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).
Time frame: at 2 weeks, 6 weeks, 3 months, 6 months
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Plan to share: No
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Hospital for Special Surgery, New York