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

Overview

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.

Interventions

• Drug Bupivacaine, Dexamethasone in Adductor Canal Block
  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
• Drug Bupivacaine, Dexamethasone in Anterior Femoral Cutaneous Nerve Block
  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

Primary outcome measures

• Postoperative Function (Motor strength in quadriceps) [Time frame: 3 months]

Secondary outcome measures (12)

• Cumulative opioid consumption (MMEs) [Time frame: 48 hours after surgery]
• Total opioid consumption (MMEs) [Time frame: at postoperative day 7 & 14]
• Opioid consumption [Time frame: 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]
• 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]
• Postoperative pain location(s) [Time frame: at 2 weeks, 6 weeks, 3 months, 6 months]
• Pain expectation scale [Time frame: at postoperative days 1, 2, 7, and 14]
• Satisfaction with pain management [Time frame: at postoperative days 1, 2, 7, and 14]
• postoperative sensation [Time frame: 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]
• postoperative function - range of motion (ROM) [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Hospital for Special Surgery — New York

Publications

• 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 16301234
• 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 36267350
• 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 25089833
• 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, PMID 30074928
• 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 33079899
• 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 27262287
• 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 28606458
• 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 27627711

Identifiers

NCT: NCT06590402 · 2024-0582

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗