Skip to main content
OpenTrials
Completed

NCT Number: NCT03704376

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center-Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

30 ml of 0.2% ropivacaine

Drug

15 ml of 0.2% ropivacaine

Drug

100 mcg clonidine

Drug

High-frequency linear ultrasound transducer

Device

Primary outcomes

  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 outcomes

  1. 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.

  2. 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.

  3. 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. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Memorial Hermann Hospital

Registry information

Official study title

Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum

Acronym: FNB vs ACB

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2018
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.