Clinical trial NCT03704376: Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction
Official title: Clinical Outcome Following Arthroscopic Knee Surgery (COFAKS)-Addendum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Injury
Keywords: Femoral Nerve Block
Adductor Canal Block
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
First posted: 2018-10-12
Enrollment: 125
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
timeFrame: Post-operative day 1
measure: Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
timeFrame: Post-operative day 14
measure: Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
timeFrame: 4 weeks post operative
Secondary outcomes:
measure: Number of Successful Repetitions With Straight Leg Raise Test
timeFrame: Post-operative day 1
measure: Number of Successful Repetitions With Straight Leg Raise Test
timeFrame: Post-operative day 14
measure: Number of Successful Repetitions With Straight Leg Raise Test
timeFrame: 4 weeks post operative
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 1 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 2 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 3 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 4 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 5 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 6 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 7 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 8 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 9 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 10 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 11 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: 12 hr post surgery
measure: Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
timeFrame: Postoperative physicians visit
measure: Narcotics Use as Assessed by Morphine Equivalents Consumed
timeFrame: Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center-Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lane Bailey, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.