Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
- Conditions
- Anterior Cruciate Ligament ReconstructionMedial Patellofemoral Ligament Reconstruction
- Interventions
- Registration Number
- NCT06590402
- Lead Sponsor
- Hospital for Special Surgery, New York
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 8-18 years old at the time of surgery
- Patients 40kg and above
- ACL reconstruction of MPFL reconstruction surgery with participating surgeons
- revision surgery
- bilateral surgery
- general anesthesia
- contraindications to any part of the study protocol
- relevant pre-existing neurological deficit
- chronic pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anterior Cruciate Ligament (ACL) surgeries Bupivacaine, Dexamethasone in Adductor Canal Block 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). Medial Patellofemoral Ligament (MPFL) surgeries Bupivacaine, Dexamethasone in Adductor Canal 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). Anterior Cruciate Ligament (ACL) surgeries Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block 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). Medial Patellofemoral Ligament (MPFL) surgeries 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).
- Primary Outcome Measures
Name Time Method Postoperative Function (Motor strength in quadriceps) 3 months Collected at standard of care postoperative clinical visits with surgeon. Quadriceps strength is measured bilaterally by a handheld dynamometer.
- Secondary Outcome Measures
Name Time Method Cumulative opioid consumption (MMEs) 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)
Total opioid consumption (MMEs) 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
Opioid consumption at 6 weeks, 3 months, 6 months defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively
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 Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
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 Defined on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Postoperative pain location(s) 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
Pain expectation scale 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.
Satisfaction with pain management 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.
postoperative sensation 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.
postoperative function - motor strength in quadriceps at 2 weeks, 6 weeks, 6 months collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer
postoperative function - range of motion (ROM) 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
postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function. 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).
Trial Locations
- Locations (1)
Hospital for Special Surgery
🇺🇸New York, New York, United States