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

September 27, 2021 updated by: Lane Bailey, The University of Texas Health Science Center, Houston

Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center-Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative day 1
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.
Post-operative day 14
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.
4 weeks post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Successful Repetitions With 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.
Post-operative day 1
Number of Successful Repetitions With 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.
Post-operative day 14
Number of Successful Repetitions With 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 weeks post operative
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.
1 hr post surgery
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.
2 hr post surgery
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
3 hr post surgery
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.
4 hr post surgery
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.
5 hr post surgery
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.
6 hr post surgery
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.
7 hr post surgery
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.
8 hr post surgery
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.
9 hr post surgery
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.
10 hr post surgery
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.
11 hr post surgery
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.
12 hr post surgery
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
Postoperative physicians visit
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.
Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Memorial Hermann Hospital

Investigators

  • Principal Investigator: Lane Bailey, PhD, PT, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

November 16, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MH-14-0734 (addendum)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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