A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine, Dexamethasone in Adductor Canal Block
- Conditions
- Anterior Cruciate Ligament Reconstruction
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Postoperative Function (Motor strength in quadriceps)
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Anterior Cruciate Ligament (ACL) surgeries
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).
Intervention: Bupivacaine, Dexamethasone in Adductor Canal Block
Anterior Cruciate Ligament (ACL) surgeries
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).
Intervention: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Medial Patellofemoral Ligament (MPFL) surgeries
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).
Intervention: Bupivacaine, Dexamethasone in Adductor Canal Block
Medial Patellofemoral Ligament (MPFL) surgeries
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).
Intervention: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
Outcomes
Primary Outcomes
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
- Cumulative opioid consumption (MMEs)(48 hours after surgery)
- Total opioid consumption (MMEs)(at postoperative day 7 & 14)
- Opioid consumption(at 6 weeks, 3 months, 6 months)
- 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)
- 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)
- Postoperative pain location(s)(at 2 weeks, 6 weeks, 3 months, 6 months)
- Pain expectation scale(at postoperative days 1, 2, 7, and 14)
- Satisfaction with pain management(at postoperative days 1, 2, 7, and 14)
- postoperative sensation(at 2 weeks, 6 weeks, 3 months, and 6 months)
- postoperative function - motor strength in quadriceps(at 2 weeks, 6 weeks, 6 months)
- postoperative function - range of motion (ROM)(at 2 weeks, 6 weeks, 3 months, 6 months)
- postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.(at 2 weeks, 6 weeks, 3 months, 6 months)