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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
30 ml of 0.2% ropivacaine
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Femoral Nerve Block, Adductor Canal Block

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center-Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Femoral Nerve Blockade

Adductor Canal Blockade

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Number of Successful Repetitions With Straight Leg Raise Test
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.
Number of Successful Repetitions With Straight Leg Raise Test
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.
Number of Successful Repetitions With Straight Leg Raise Test
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.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Narcotics Use as Assessed by Morphine Equivalents Consumed
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.

Full Information

First Posted
September 27, 2018
Last Updated
September 27, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03704376
Brief Title
Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction
Acronym
FNB vs ACB
Official Title
Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
Femoral Nerve Block, Adductor Canal Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral Nerve Blockade
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Adductor Canal Blockade
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
30 ml of 0.2% ropivacaine
Intervention Type
Drug
Intervention Name(s)
15 ml of 0.2% ropivacaine
Intervention Type
Drug
Intervention Name(s)
100 mcg clonidine
Intervention Type
Device
Intervention Name(s)
High-frequency linear ultrasound transducer
Primary Outcome Measure Information:
Title
Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
Description
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.
Time Frame
Post-operative day 1
Title
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Description
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.
Time Frame
Post-operative day 14
Title
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Description
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.
Time Frame
4 weeks post operative
Secondary Outcome Measure Information:
Title
Number of Successful Repetitions With Straight Leg Raise Test
Description
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.
Time Frame
Post-operative day 1
Title
Number of Successful Repetitions With Straight Leg Raise Test
Description
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.
Time Frame
Post-operative day 14
Title
Number of Successful Repetitions With Straight Leg Raise Test
Description
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.
Time Frame
4 weeks post operative
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Time Frame
1 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
2 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time Frame
3 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
4 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
5 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
6 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
7 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
8 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
9 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
10 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
11 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame
12 hr post surgery
Title
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Description
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time Frame
Postoperative physicians visit
Title
Narcotics Use as Assessed by Morphine Equivalents Consumed
Description
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.
Time Frame
Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lane Bailey, PhD, PT
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34477016
Citation
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.
Results Reference
derived
PubMed Identifier
31348866
Citation
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.
Results Reference
derived
PubMed Identifier
30733025
Citation
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.
Results Reference
derived

Learn more about this trial

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

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