- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06590402
Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Alex Sideris, PhD
- Phone Number: 212-774-2602
- Email: Siderisa@hss.edu
Study Contact Backup
- Name: Marko Popovic
- Phone Number: 646-797-8948
- Email: popovicm@hss.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery
-
Contact:
- Jashvant Poeran, MD/PhD
- Email: poeranj@hss.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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).
|
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
Other Names:
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
Other Names:
|
|
Experimental: 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).
|
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
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioid consumption (MMEs)
Time Frame: 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
|
at postoperative day 7 & 14
|
|
postoperative sensation
Time Frame: 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.
|
at 2 weeks, 6 weeks, 3 months, and 6 months
|
|
postoperative function - motor strength in quadriceps
Time Frame: at 2 weeks, 6 weeks, 6 months
|
collected at standard of care postoperative clinical visits with surgeon; quadriceps strength: measured bilaterally by handheld dynamometer
|
at 2 weeks, 6 weeks, 6 months
|
|
postoperative function - range of motion (ROM)
Time Frame: 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
|
at 2 weeks, 6 weeks, 3 months, 6 months
|
|
postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.
Time Frame: 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).
|
at 2 weeks, 6 weeks, 3 months, 6 months
|
|
Cumulative opioid consumption (MMEs)
Time Frame: 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)
|
48 hours after surgery
|
|
Opioid consumption
Time Frame: at 6 weeks, 3 months, 6 months
|
defined as any opioid consumption at 6 weeks, 3 months, 6 months postoperatively
|
at 6 weeks, 3 months, 6 months
|
|
Pain Numerical Rating Scale (NRS) at rest
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
|
Defined on a scale of 0-10, where 0 is no pain and 10 is the worst pain imaginable.
|
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
Time Frame: 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.
|
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)
Time Frame: 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
|
at 2 weeks, 6 weeks, 3 months, 6 months
|
|
Pain expectation scale
Time Frame: 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.
|
at postoperative days 1, 2, 7, and 14
|
|
Satisfaction with pain management
Time Frame: 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.
|
at postoperative days 1, 2, 7, and 14
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kathryn DelPizzo, MD, Hospital for Special Surgery, New York
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-0582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anterior Cruciate Ligament Reconstruction
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Federal University of Health Science of Porto AlegreRecruitingAnterior Cruciate Ligament Reconstruction | Anterior Cruciate Ligament Reconstruction RehabilitationBrazil
-
Egas Moniz - Cooperativa de Ensino Superior, CRLRecruitingAnterior Cruciate Ligament Reconstruction | Athlete | Anterior Cruciate Ligament Reconstruction RehabilitationPortugal
-
Hacettepe UniversityRecruitingAnterior Cruciate Ligament Reconstruction Rehabilitation | Strength Outcomes | Anterior Cruciate Ligament (ACL) Reconstruction SurgeryTurkey (Türkiye)
-
University of Sao Paulo General HospitalUnknownAnterior Cruciate Ligament Reconstruction | Rehabilitation | Anterolateral Ligament ReconstructionBrazil
-
Universiti Sains MalaysiaNot yet recruitingAnterior Cruciate Ligament ReconstructionChina
-
Marquette UniversityRecruitingAnterior Cruciate Ligament ReconstructionUnited States
-
Assaf-Harofeh Medical CenterRecruitingAnterior Cruciate Ligament ReconstructionIsrael
-
Linnaeus UniversityNot yet recruitingAnterior Cruciate Ligament ReconstructionSweden
-
University of ConnecticutNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingAnterior Cruciate Ligament ReconstructionUnited States
Clinical Trials on Bupivacaine, Dexamethasone in Adductor Canal Block
-
Benaroya Research InstituteCompletedPost-Operative PainUnited States
-
Konya Beyhekim Training and Research HospitalNot yet recruitingTotal Knee Arthroplasty | Adductor Canal Block | IPACK Block Multimodal Analgesia | Genicular Nerves Block
-
Yonsei UniversityNot yet recruitingPostoperative Pain | Knee Osteoarthritis | Total Knee Arthroplasty | Peripheral Nerve Block | Adductor Canal Block
-
Karaman Training and Research HospitalCompletedOsteo Arthritis KneeTurkey
-
Ain Shams UniversityNot yet recruitingFunctional Recovery | Adductor Canal Block | Total Knee Replacement Surgery
-
Fayoum University HospitalNot yet recruiting
-
Ankara Etlik City HospitalActive, not recruitingPostoperative Pain | Total Knee AnthroplastyTurkey (Türkiye)
-
Lawson Health Research InstituteCompleted
-
TC Erciyes UniversityRecruitingKnee Arthroplasty, TotalTurkey (Türkiye)
-
Seoul National University HospitalSeoul National UniversityCompletedPostoperative PainKorea, Republic of