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

NCT ID: NCT03704376

Last Updated: 2021-10-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-11-16

Brief Summary

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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.

Detailed Description

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Adequate pain control following anterior cruciate ligament reconstruction (ACL) often requires a regional nerve block. The femoral nerve block (FNB) has been traditionally employed. More recently, ultrasound application to regional nerve blocks allows for the use of alternatives such as the adductor canal block following ACL reconstruction. In 2009, Manickam et al. were the first to describe the ultrasound guided adductor canal technique for the purposes of knee joint analgesia. Unlike other traditional techniques that seek to cause a sensory as well as a motor blockade, the adductor canal block attempts to spare the motor block of the neighboring distributions in an attempt to offer selective analgesia and strength preservation. Chisholm et al demonstrated the adductor canal block provides similar and adequate postoperative analgesia when compared to the FNB, following arthroscopic ACL reconstruction with patellar tendon autograft. Their study focused on analgesia and did not evaluate quadriceps function or impact on rehabilitation. Sharma et al drew the first association between femoral nerve blocks and increased fall risk due to muscle weakness in total knee arthroplasty population. A randomized, blinded study to compare quadriceps strength following adductor canal versus FNB was performed by Kwofie et al. They showed that compared with FNB, adductor canal block results in significant quadriceps motor sparing and significantly preserved balance. These studies focused on acute muscle weakness after regional anesthesia and its relation to safety. Quadriceps function is very important in rehabilitation of ACL reconstruction. Luo et al demonstrated long term deficits related to FNB. They demonstrated that patients treated with FNB after ACL reconstruction had significant isokinetic deficits in knee extension and flexion strength at 6 months when compared with patients who did not receive a nerve block. Patients without a block were 4 times more likely to meet criteria for clearance to return to sports at 6 months. In addition, Krych et al found significantly inferior quadriceps strength and function at 6 months in FNB group. Based on the available literature, we aim to compare femoral nerve versus adductor canal block in regards to pain control and muscle strength in ACL reconstruction patients until return to sport.

Conditions

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Anterior Cruciate Ligament Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Femoral Nerve Blockade

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.

Group Type ACTIVE_COMPARATOR

30 ml of 0.2% ropivacaine

Intervention Type DRUG

100 mcg clonidine

Intervention Type DRUG

High-frequency linear ultrasound transducer

Intervention Type DEVICE

Adductor Canal Blockade

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).

Group Type ACTIVE_COMPARATOR

15 ml of 0.2% ropivacaine

Intervention Type DRUG

100 mcg clonidine

Intervention Type DRUG

High-frequency linear ultrasound transducer

Intervention Type DEVICE

Interventions

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30 ml of 0.2% ropivacaine

Intervention Type DRUG

15 ml of 0.2% ropivacaine

Intervention Type DRUG

100 mcg clonidine

Intervention Type DRUG

High-frequency linear ultrasound transducer

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not enrolled within the COFAKS study
* Receiving intrathecal nerve blockade or no blockade
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Hermann Hospital

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Lane Bailey

Director of Research and Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lane Bailey, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center-Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37152546 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36860772 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34477016 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31348866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30733025 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HSC-MH-14-0734 (addendum)

Identifier Type: -

Identifier Source: org_study_id