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:
Organization:
Raw JSON
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Quadriceps strength is measured bilaterally by a handheld dynamometer.'}], 'secondaryOutcomes': [{'measure': 'Cumulative opioid consumption (MMEs)', 'timeFrame': '48 hours after surgery', 'description': '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)'}, {'measure': 'Total opioid consumption (MMEs)', 'timeFrame': 'at postoperative day 7 & 14', 'description': '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'}, {'measure': 'Opioid consumption', 'timeFrame': 'at 6 weeks, 3 months, 6 months', 'description': 'defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively'}, {'measure': 'Pain Numerical Rating Scale (NRS) at rest', 'timeFrame': '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', 'description': 'Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Pain Numerical Rating Scale (NRS) with ambulation', 'timeFrame': 'preop (baseline); in PACU; at 6 hours, 24 hours, 48 hours, 7 days, 14 days, 6 weeks, 3 months, 6 months postoperatively', 'description': 'Defined on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.'}, {'measure': 'Postoperative pain location(s)', 'timeFrame': 'at 2 weeks, 6 weeks, 3 months, 6 months', 'description': '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'}, {'measure': 'Pain expectation scale', 'timeFrame': 'at postoperative days 1, 2, 7, and 14', 'description': '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.'}, {'measure': 'Satisfaction with pain management', 'timeFrame': 'at postoperative days 1, 2, 7, and 14', 'description': 'measured on a scale from 0 to 10, where 0 is very dissatisfied and 10 is very satisfied with the pain management regimen.'}, {'measure': 'postoperative sensation', 'timeFrame': 'at 2 weeks, 6 weeks, 3 months, and 6 months', 'description': '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.'}, {'measure': 'postoperative function - motor strength in quadriceps', 'timeFrame': 'at 2 weeks, 6 weeks, 6 months', 'description': 'collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer'}, {'measure': 'postoperative function - range of motion (ROM)', 'timeFrame': 'at 2 weeks, 6 weeks, 3 months, 6 months', 'description': 'collected at standard of care postoperative clinical visits with surgeon; range of motion (ROM): measured bilaterally by goniometer'}, {'measure': 'postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.', 'timeFrame': 'at 2 weeks, 6 weeks, 3 months, 6 months', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Reconstruction', 'Medial Patellofemoral Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '16301234', 'type': 'BACKGROUND', 'citation': 'Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005 Dec;101(6):1634-1642. doi: 10.1213/01.ANE.0000180829.70036.4F.'}, {'pmid': '36267350', 'type': 'BACKGROUND', 'citation': 'Wang C, Liu LD, Bai X. Bibliometric and Visual Analysis of the Current Status and Trends of Postoperative Pain in Children from 1950-2021. J Pain Res. 2022 Oct 14;15:3209-3222. doi: 10.2147/JPR.S380842. eCollection 2022.'}, {'pmid': '25089833', 'type': 'BACKGROUND', 'citation': 'Micalizzi RA, Williams LA, Pignataro S, Sethna NF, Zurakowski D. Review of outcomes in pediatric patients undergoing anterior cruciate ligament repairs with regional nerve blocks. J Pediatr Nurs. 2014 Nov-Dec;29(6):670-8. doi: 10.1016/j.pedn.2014.07.002. Epub 2014 Jul 13.'}, {'pmid': '30074928', 'type': 'BACKGROUND', 'citation': 'Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.'}, {'pmid': '33079899', 'type': 'BACKGROUND', 'citation': 'Yee EJ, Gapinski ZA, Ziemba-Davis M, Nielson M, Meneghini RM. Quadriceps Weakness After Single-Shot Adductor Canal Block: A Multivariate Analysis of 1,083 Primary Total Knee Arthroplasties. J Bone Joint Surg Am. 2021 Jan 6;103(1):30-36. doi: 10.2106/JBJS.19.01425.'}, {'pmid': '27262287', 'type': 'BACKGROUND', 'citation': 'Zhao XQ, Jiang N, Yuan FF, Wang L, Yu B. The comparison of adductor canal block with femoral nerve block following total knee arthroplasty: a systematic review with meta-analysis. J Anesth. 2016 Oct;30(5):745-54. doi: 10.1007/s00540-016-2194-1. Epub 2016 Jun 4.'}, {'pmid': '28606458', 'type': 'BACKGROUND', 'citation': 'Kuang MJ, Ma JX, Fu L, He WW, Zhao J, Ma XL. Is Adductor Canal Block Better Than Femoral Nerve Block in Primary Total Knee Arthroplasty? A GRADE Analysis of the Evidence Through a Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Oct;32(10):3238-3248.e3. doi: 10.1016/j.arth.2017.05.015. Epub 2017 May 17.'}, {'pmid': '27627711', 'type': 'BACKGROUND', 'citation': 'Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268.'}, {'pmid': '30649069', 'type': 'BACKGROUND', 'citation': 'Abdallah FW, Brull R, Joshi GP; Society for Ambulatory Anesthesia (SAMBA). Pain Management for Ambulatory Arthroscopic Anterior Cruciate Ligament Reconstruction: Evidence-Based Recommendations From the Society for Ambulatory Anesthesia. Anesth Analg. 2019 Apr;128(4):631-640. doi: 10.1213/ANE.0000000000003976.'}, {'pmid': '26938989', 'type': 'BACKGROUND', 'citation': 'Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045.'}, {'pmid': '29152521', 'type': 'BACKGROUND', 'citation': 'Christensen JE, Taylor NE, Hetzel SJ, Shepler JA, Scerpella TA. Isokinetic Strength Deficit 6 Months After Adductor Canal Blockade for Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2017 Nov 8;5(11):2325967117736249. doi: 10.1177/2325967117736249. eCollection 2017 Nov.'}, {'pmid': '34368383', 'type': 'BACKGROUND', 'citation': 'Frazer AR, Chausse ME, Held M, St-Pierre C, Tsai CY, Preuss R, Descoteaux N, Chan M, Martineau PA, Veilleux LN. Quadriceps and Hamstring Strength in Adolescents 6 Months After ACL Reconstruction With Femoral Nerve Block, Adductor Canal Block, or No Nerve Block. Orthop J Sports Med. 2021 Jul 22;9(7):23259671211017516. doi: 10.1177/23259671211017516. eCollection 2021 Jul.'}], 'seeAlsoLinks': [{'url': 'http://www.youtube.com/watch?v=zzj08axeE94', 'label': 'Anterior Femoral Cutaneous Nerve Block (Dr. Jeff Gadsden)'}, {'url': 'http://www.youtube.com/watch?v=bAxMvcTf0kU', 'label': 'Anterior Femoral Cutaneous Nerve Block (Dr. Amit Pawa)'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* To measure postoperative functional outcomes in patients who received AFCNB vs. ACB.\n* To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB.\n* To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB.\n* To quantify sensory deficits in patients who received AFCNB vs. ACB.\n* 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.\n\nSubjects 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.\n\nParticipants will:\n\n* Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia.\n* Maintain a patient diary to document daily pain meds/pain scores\n* Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.', 'detailedDescription': '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.\n\nThis 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:\n\n* To measure postoperative functional outcomes in patients who received AFCNB vs. ACB.\n* To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB.\n* To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB.\n* To quantify sensory deficits in patients who received AFCNB vs. ACB.\n* 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.\n\n 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).\n\nEligible and enrolled participants will:\n\n* Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia.\n* Maintain a patient diary to document daily pain meds/pain scores\n* Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-18 years old at the time of surgery\n* Patients 40kg and above\n* ACL reconstruction of MPFL reconstruction surgery with participating surgeons\n\nExclusion Criteria:\n\n* revision surgery\n* bilateral surgery\n* general anesthesia\n* contraindications to any part of the study protocol\n* relevant pre-existing neurological deficit\n* chronic pain'}, 'identificationModule': {'nctId': 'NCT06590402', 'briefTitle': 'Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries', 'orgStudyIdInfo': {'id': '2024-0582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anterior Cruciate Ligament (ACL) surgeries', 'description': '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).', 'interventionNames': ['Drug: Bupivacaine, Dexamethasone in Adductor Canal Block', 'Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block']}, {'type': 'EXPERIMENTAL', 'label': 'Medial Patellofemoral Ligament (MPFL) surgeries', 'description': '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).', 'interventionNames': ['Drug: Bupivacaine, Dexamethasone in Adductor Canal Block', 'Drug: Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block']}], 'interventions': [{'name': 'Bupivacaine, Dexamethasone in Adductor Canal Block', 'type': 'DRUG', 'otherNames': ['Adductor Canal Block (ACB)'], 'description': '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', 'armGroupLabels': ['Anterior Cruciate Ligament (ACL) surgeries', 'Medial Patellofemoral Ligament (MPFL) surgeries']}, {'name': 'Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block', 'type': 'DRUG', 'otherNames': ['Anterior Femoral Cutaneous Nerve Block (AFCNB)'], 'description': '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', 'armGroupLabels': ['Anterior Cruciate Ligament (ACL) surgeries', 'Medial Patellofemoral Ligament (MPFL) surgeries']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jashvant Poeran, MD/PhD', 'role': 'CONTACT', 'email': 'poeranj@hss.edu'}], 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Marko Popovic', 'role': 'CONTACT', 'email': 'popovicm@hss.edu', 'phone': '646-797-8948'}, {'name': 'Alex Sideris, PhD', 'role': 'CONTACT', 'email': 'Siderisa@hss.edu', 'phone': '212-774-2602'}], 'overallOfficials': [{'name': 'Kathryn DelPizzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}