Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction

NCT03704376 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MH-14-0734 (addendum)
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the potential differences between femoral nerve blockade (FNB) and adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients following anterior cruciate ligament (ACL) reconstruction.

Conditions

Anterior Cruciate Ligament Injury

Keywords

Femoral Nerve Block; Adductor Canal Block

Outcome Measures

Primary Outcomes (3)

• Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)

  Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.

  Post-operative day 1

• Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)

  Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.

  Post-operative day 14

• Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)

  Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.

  4 weeks post operative

Secondary Outcomes (17)

• Number of Successful Repetitions With Straight Leg Raise Test

  Post-operative day 1

• Number of Successful Repetitions With Straight Leg Raise Test

  Post-operative day 14

• Number of Successful Repetitions With Straight Leg Raise Test

  4 weeks post operative

• Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale

  1 hr post surgery

• Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale

  2 hr post surgery

Study Arms (2)

Femoral Nerve Blockade

ACTIVE COMPARATOR

Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.

Drug: 30 ml of 0.2% ropivacaine; Drug: 100 mcg clonidine; Device: High-frequency linear ultrasound transducer

Adductor Canal Blockade

ACTIVE COMPARATOR

Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).

Drug: 15 ml of 0.2% ropivacaine; Drug: 100 mcg clonidine; Device: High-frequency linear ultrasound transducer

Interventions

30 ml of 0.2% ropivacaine DRUG

Femoral Nerve Blockade

15 ml of 0.2% ropivacaine DRUG

Adductor Canal Blockade

100 mcg clonidine DRUG

Adductor Canal Blockade; Femoral Nerve Blockade

High-frequency linear ultrasound transducer DEVICE

Adductor Canal Blockade; Femoral Nerve Blockade

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males \& Females ages 16-30 yrs
• Undergoing ACL reconstruction by Co-Investigator (Walter Lowe)
• Receiving peri-operative FNB or ACB

You may not qualify if:

• Not enrolled within the COFAKS study
• Receiving intrathecal nerve blockade or no blockade

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Memorial Hermann Hospital: collaborator

Study Sites (1)

The University of Texas Health Science Center-Houston

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Duncan BR, Reid M, Kleihege J, Higbie S, Gardner EP, Lowe W, Bailey L. Comparison of Psychological Readiness to Return to Sport After Primary Versus Revision Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2023 May 2;11(5):23259671231159408. doi: 10.1177/23259671231159408. eCollection 2023 May.

  PMID: 37152546 DERIVED

• Galloway C, Ward H, Higbie S, Kleihege J, Kumaravel M, Lowe WR, Bailey L. Relationship Between Bone Bruise Volume and Patient Outcomes After ACL Reconstruction. Orthop J Sports Med. 2023 Feb 24;11(2):23259671221146205. doi: 10.1177/23259671221146205. eCollection 2023 Feb.

  PMID: 36860772 DERIVED

• Bailey L, Weldon M, Kleihege J, Lauck K, Syed M, Mascarenhas R, Lowe WR. Platelet-Rich Plasma Augmentation of Meniscal Repair in the Setting of Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Oct;49(12):3287-3292. doi: 10.1177/03635465211036471. Epub 2021 Sep 3.

  PMID: 34477016 DERIVED

• Worsham J, Lowe WR, Copa D, Williams S, Kleihege J, Lauck K, Mascarenhas R, Bailey L. Subsequent Surgery for Loss of Motion After Anterior Cruciate Ligament Reconstruction Does Not Influence Function at 2 Years: A Matched Case-Control Analysis. Am J Sports Med. 2019 Sep;47(11):2550-2556. doi: 10.1177/0363546519863347. Epub 2019 Jul 26.

  PMID: 31348866 DERIVED

• Bailey L, Griffin J, Elliott M, Wu J, Papavasiliou T, Harner C, Lowe W. Adductor Canal Nerve Versus Femoral Nerve Blockade for Pain Control and Quadriceps Function Following Anterior Cruciate Ligament Reconstruction With Patellar Tendon Autograft: A Prospective Randomized Trial. Arthroscopy. 2019 Mar;35(3):921-929. doi: 10.1016/j.arthro.2018.10.149. Epub 2019 Feb 4.

  PMID: 30733025 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Ropivacaine; Clonidine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lane Bailey, PhD, PT
• Organization: The University of Texas Health Science Center at Houston

lane.bailey@uth.tmc.edu

713-704-6794

Study Officials

• Lane Bailey, PhD, PT

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Education

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 12, 2018
• Study Start: February 1, 2016
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: October 21, 2021
• Results First Posted: December 11, 2018

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)