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Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction (FNB vs ACB)

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ClinicalTrials.gov Identifier: NCT03704376
Recruitment Status : Active, not recruiting
First Posted : October 12, 2018
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Memorial Hermann Hospital
Information provided by (Responsible Party):
Lane Bailey, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Drug: 30 ml of 0.2% ropivacaine Drug: 15 ml of 0.2% ropivacaine Drug: 100 mcg clonidine Device: High-frequency linear ultrasound transducer Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : November 16, 2017
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: 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.
Drug: 30 ml of 0.2% ropivacaine
Drug: 100 mcg clonidine
Device: High-frequency linear ultrasound transducer
Active Comparator: 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).
Drug: 15 ml of 0.2% ropivacaine
Drug: 100 mcg clonidine
Device: High-frequency linear ultrasound transducer



Primary Outcome Measures :
  1. Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG) [ Time Frame: Post-operative day 1 ]
    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.

  2. Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) [ Time Frame: Post-operative day 14 ]
    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.

  3. Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) [ Time Frame: 4 weeks post operative ]
    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.


Secondary Outcome Measures :
  1. Straight Leg Raise Test [ Time Frame: Post-operative day 1 ]
    The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.

  2. Straight Leg Raise Test [ Time Frame: Post-operative day 14 ]
    The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.

  3. Straight Leg Raise Test [ Time Frame: 4 weeks post operative ]
    The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.

  4. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 1 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.

  5. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 2 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  6. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 3 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better

  7. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 4 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  8. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 5 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  9. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 6 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  10. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 7 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  11. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 8 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  12. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 9 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  13. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 10 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  14. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 11 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  15. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: 12 hr post surgery ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.

  16. Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale [ Time Frame: Postoperative physicians visit ]
    The items are scored on a visual analogical scale from 0-10, with 0 being the better

  17. Narcotics Use as Assessed by Morphine Equivalents Consumed [ Time Frame: Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery ]
    morphine equivalents consumed during the entire post-anesthesia care unit (PACU) visit post surgery will be obtained from the All-scripts electronic medical record (EMR) system.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704376


Locations
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United States, Texas
The University of Texas Health Science Center-Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Memorial Hermann Hospital
Investigators
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Principal Investigator: Lane Bailey, PhD, PT The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Lane Bailey, The University of Texas Health Science Center, Houston:

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Responsible Party: Lane Bailey, Director of Research and Education, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03704376     History of Changes
Other Study ID Numbers: HSC-MH-14-0734 (addendum)
First Posted: October 12, 2018    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lane Bailey, The University of Texas Health Science Center, Houston:
Femoral Nerve Block
Adductor Canal Block

Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries
Ropivacaine
Clonidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action