Ultrasound Guided Adductor Canal Versus Femoral Nerve Blocks for Anterior Cruciate Ligament Reconstruction in Pediatrics

NCT03053401 | Completed Results DMC

• 1 other identifier: 001126
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge, no comparison has been made between those blocks in relation to postoperative quadriceps muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL reconstruction in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee surgery comparable to FNB, it has the potential to improve the postoperative outcome as it will lead to less quadriceps muscle weakness and early mobilization, both of which are very important in the early postoperative period.

Conditions

Post-operative Pain; Quadriceps Muscle Strength

Keywords

Quadriceps muscle strength; Anterior cruciate ligament reconstruction; Femoral nerve block; Adductor Canal block; Saphenous nerve block in the Adductor Canal; Pediatrics; Postoperative analgesia; Ultrasound guided nerve block

Outcome Measures

Primary Outcomes (3)

• Quadriceps Muscle Strength in Kilogram-force (Kgf)

  Measuring the quadriceps muscle strength (surgical side) using a dynamometer.Patients were placed supine with a cushion underneath their knee, resulting in a 45-degree angle at the knee. A dynamometer was placed on the anterior of the ankle, between the malleoli. Patients were instructed to extend their legs three times each, with a 30-s pause between each attempt (Lafayette Manual Muscle Test System; Lafayette Instrument Company, Lafayette, IN; and all three dynamometer readings in Kgf unit for each leg were recorded.Kgf is a gravitational metric unit force ,it is equal to the magnitude of the force exerted on one kilogram of mass under standard gravity.

  4 hours following peripheral nerve block performance

• Post-operative Pain Scores Using the Numeric Pain Scoring System (NS)

  Assessed by Numeric Scale (NS) pain scoring system. Minimum 0 and maximum 10 . Higher scores means worse outcome (pain)

  4 hours and 24 hours

• Total Opioid Consumption at 24 Hours Post-block

  Total intravenous morphine/morphine equivalent consumption in milligrams (mg) at 24 hours post-block

  24 hours following peripheral nerve block performance.

Study Arms (2)

Adductor Canal block

ACTIVE COMPARATOR

Adductor Canal Block performed at mid-thigh level to block the saphenous nerve under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).

Procedure: Adductor Canal Block; Device: Ultrasound; Device: Stimuplex A needle; Drug: local anaesthetic injection; Drug: Steroid Drug

Femoral Nerve block

ACTIVE COMPARATOR

Femoral Nerve Block performed under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).

Procedure: Femoral Nerve Block; Device: Ultrasound; Device: Stimuplex A needle; Drug: local anaesthetic injection; Drug: Steroid Drug

Interventions

Adductor Canal Block PROCEDURE

Under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).

Adductor Canal block

Femoral Nerve Block PROCEDURE

Under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).

Femoral Nerve block

Ultrasound DEVICE

Use of linear ultrasound transducer probe (General Electric;GE) to guide needle placement for both Adductor Canal Block and Femoral nerve Blocks

Adductor Canal block; Femoral Nerve block

Stimuplex A needle DEVICE

22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany) used to perform both Adductor Canal Block and Femoral nerve Blocks.

Adductor Canal block; Femoral Nerve block

local anaesthetic injection DRUG

Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) for either Adductor Canal Block and Femoral nerve Blocks.

Adductor Canal block; Femoral Nerve block

Steroid Drug DRUG

Methylprednisolone acetate 1 mg/kg (maximum of 40 mg ) for either Adductor Canal Block and Femoral nerve Blocks.

Adductor Canal block; Femoral Nerve block

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ASA I or II
• Age 8 to 18 years
• All research subjects must have an acceptable legally authorized representative capable of giving consent on the subject's behalf.

You may not qualify if:

• Those who were unable to use a standard 0-10 NS
• Infection at the site of the block
• Bleeding disorders
• Allergy to the drugs used to perform the block ( ropivacaine , methylprednisolone)
• Those who refused a nerve block or enrollment in the study.

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (12)

• Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

  PMID: 24121608 RESULT

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 RESULT

• Atkinson HD, Hamid I, Gupte CM, Russell RC, Handy JM. Postoperative fall after the use of the 3-in-1 femoral nerve block for knee surgery: a report of four cases. J Orthop Surg (Hong Kong). 2008 Dec;16(3):381-4. doi: 10.1177/230949900801600324.

  PMID: 19126912 RESULT

• Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.

  PMID: 19046884 RESULT

• Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

  PMID: 19916251 RESULT

• Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.

  PMID: 22834681 RESULT

• Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.

  PMID: 18574578 RESULT

• Horn JL, Pitsch T, Salinas F, Benninger B. Anatomic basis to the ultrasound-guided approach for saphenous nerve blockade. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):486-9. doi: 10.1097/AAP.0b013e3181ae11af.

  PMID: 19920424 RESULT

• Krombach J, Gray AT. Sonography for saphenous nerve block near the adductor canal. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):369-70. doi: 10.1016/j.rapm.2007.04.006. No abstract available.

  PMID: 17720129 RESULT

• Maffiuletti NA. Assessment of hip and knee muscle function in orthopaedic practice and research. J Bone Joint Surg Am. 2010 Jan;92(1):220-9. doi: 10.2106/JBJS.I.00305.

  PMID: 20048117 RESULT

• 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: 26938989 RESULT

• Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.

  PMID: 25466410 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultrasonography; Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

The sample size analysis was known to be limited due to population differences between our site and the site referenced. Due to feasibility issues the study was concluded as planned with completed enrollment of 52 subjects.

Results Point of Contact

• Title: Dr. Rami Karroum
• Organization: Akron Children's Hospital

rkarroum@akronchildrens.org

330-543-8823

Study Officials

• Rami Karroum, MD

  Akron Chidren's hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anethesiologist,M.D.

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 15, 2017
• Study Start: February 9, 2017
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: December 28, 2020
• Results First Posted: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)