Clinical trial NCT06590402: Anterior Femoral and Adductor Canal Nerve Blocks in Peds Knees
Official title: A Pilot Study Comparing Anterior Femoral Cutaneous Nerve Blocks to Adductor Canal Blocks in Pediatric Ambulatory Knee Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Reconstruction
Medial Patellofemoral Ligament Reconstruction
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blinded pilot parallel group-randomized trial (GRT), subjects are enrolled and randomized based on their condition, and there is no cross-over of the groups
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Postoperative Function (Motor strength in quadriceps)
timeFrame: 3 months
Secondary outcomes:
measure: Cumulative opioid consumption (MMEs)
timeFrame: 48 hours after surgery
measure: Total opioid consumption (MMEs)
timeFrame: at postoperative day 7 & 14
measure: Opioid consumption
timeFrame: at 6 weeks, 3 months, 6 months
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
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
measure: Postoperative pain location(s)
timeFrame: at 2 weeks, 6 weeks, 3 months, 6 months
measure: Pain expectation scale
timeFrame: at postoperative days 1, 2, 7, and 14
measure: Satisfaction with pain management
timeFrame: at postoperative days 1, 2, 7, and 14
measure: postoperative sensation
timeFrame: at 2 weeks, 6 weeks, 3 months, and 6 months
measure: postoperative function - motor strength in quadriceps
timeFrame: at 2 weeks, 6 weeks, 6 months
measure: postoperative function - range of motion (ROM)
timeFrame: at 2 weeks, 6 weeks, 3 months, 6 months
measure: postoperative function - Patient-Reported Outcomes Measurement Information System (PROMIS) physical function.
timeFrame: at 2 weeks, 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kathryn DelPizzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.