Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Anterior Cruciate Ligament Repair in Pediatrics



Status:Recruiting
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:8 - 18
Updated:1/14/2018
Start Date:July 2016
End Date:June 30, 2019
Contact:Rami E Karroum, MD
Email:rkarroum@chmca.org
Phone:330-543-8823

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Ultrasound Guided Single Shot Adductor Canal Block (ACB) Versus Single Shot Femoral Nerve Block (FNB) for Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament (ACL) Repair in Pediatrics

Both Ultrasound guided Adductor Canal Block ( ACB) and Femoral Nerve Block (FNB) has been
used to provide postoperative analgesia for knee surgeries. To the investigators' knowledge,
no comparison has been made between these blocks in relation to postoperative quadriceps
muscle strength, or duration and quality of postoperative analgesia for arthroscopic ACL
repair in pediatrics. If ACB provides postoperative analgesia after arthroscopic knee surgery
comparable to FNB, it has the potential to improve the postoperative outcome as it will lead
to less quadriceps muscle weakness and early mobilization, both of which are very important
in the early postoperative period.

Motor preservation with adequate analgesia has become the optimal postoperative goal in
orthopedic surgeries, in particular knee surgeries. This enables earlier physical therapy,
faster recovery and shorter hospital stays. Both Ultrasound guided ACB and FNB has been used
to provide postoperative analgesia for knee surgeries, including anterior cruciate ligament
reconstruction . To the investigators' knowledge, no comparison has been made between both
blocks in relation to postoperative quadriceps muscle strength as well as duration and
quality of postoperative analgesia for arthroscopic ACL repair. ACB predominantly block the
sensory component of the femoral nerve without much effect on the motor component. Hence, it
can lead to less quadriceps muscle weakness, early postoperative mobilization and decreases
the incidence of postoperative fall . With the advent of ultrasonography, the adductor canal
can be easily visualized at the mid-thigh level, allowing performance of ACB with a high
success rate . In recent years, ACB has been successfully used for postoperative pain control
after knee surgery . Anatomical study of adductor canal demonstrated that the adductor canal
may serve as a conduit for more than just the saphenous nerve, possibly including the vastus
medialis nerve, medial femoral cutaneous nerve, articular branches from the obturator nerve,
as well as the medial retinacular nerve . Thus, the sensory change is not limited to the
distribution of the saphenous nerve but includes the medial and anterior aspects of the knee
from the superior pole of the patella to the proximal tibia.To the investigators Knowledge
there has not been a randomized controlled study comparing ACB with FNB after Arthroscopic
Anterior Cruciate Ligament (ACL) repair. This prospective, double-blinded, randomized,
controlled study will test the hypothesis that ACB would be associated with less quadriceps
motor weakness than FNB at 4 hours after block performance . The investigators also
hypothesize that ACB will provide analgesia that is not inferior to FNB and not different in
opioids usage at 4 and 24 hours after Peripheral Nerve Block (PNB) performance .

- Hypothesis ACB would be associated with less quadriceps motor weakness than FNB and
provide analgesia that is not inferior to FNB in quality or duration as determined by
Numeric Scale (NS) pain scores and opioid use a 4 and 24 hours after PNB.

- Objectives

To compare FNB and ACB regarding:

1. Quadriceps muscle strength in immediate pre-operative period and at 4 hours after PNB
performance.

2. Pain scores at rest at 4 hours and 24 hours after PNB as assessed by Numeric Scale (NS)
pain scoring system.

3. Total opioid consumption at 4 and 24 hours after PNB.

- Study Design:

Randomized, double blinded, single center clinical trial. A total of 50 pediatric patients
(ASA 1or 2), aged between 8 to 18 years, for elective ACL repair at Akron Children's Hospital
( ACH ) will be enrolled in the study. Patients will be randomly assigned to one of two
groups, A or B. Group A (25 patients) will have ultrasound guided ACB performed at mid-thigh
level and group B (25 patients) will have ultrasound guided FNB, with nerve stimulator
confirmation with the type of motor response (e.g., quadriceps, patellar) and the minimum
current needed to be recorded. Both blocks will be performed under general anesthesia. Both
group will have ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml and methylprednisolone
acetate 1 mg/kg , maximum of 40 mg ).Both blocks will be performed using a 22-gauge 2-inch
Stimuplex A needle; ; B. Braun Medical Inc., Melsungen, Germany).Both blocks will be
performed using linear ultrasound transducer, General Electric ( GE). Ultrasound pictures
will be obtained to Verify proper local anesthetic placement.ACL repair, which is the
surgical procedure used in this study may not always be possible to perform by the surgeon.
The alternative is ACL reconstruction, using a hamstring graft. Post-operative pain related
to the hamstring graft arises from the distribution of sciatic nerve and is not covered by
either ACB or FNB and requires management with IV /oral opioids. The potential increase in
opioids consumption and pain scores due to sciatic nerve involvement may confound the
statistical analysis of the data and is therefore not within the scope or aims of this study.
The investigators decided therefore to continue the study procedures and data collection on
both ACL repair and ACL reconstruction. However, to improve the accuracy of the study
results, the statistical analysis will include only patients that undergo ACL repair. For the
other patients that undergo ACL reconstruction, the investigators will collect the data but
will not include it in the statistical analysis. The data from these patients may be used as
a pilot for future research.

Quadriceps strength of both legs will be assessed by placing the dynamometer on the anterior
of the ankle, between the malleoli. Patients will be instructed to extend their legs three
times each, with a 30 seconds pause between each attempt as described by Maffiuletti . The
assessment will be performed in the pre-operative period and will be repeated postoperatively
at 4 hours after PNB. All patients will be observed in the post-operative period by an
observer unaware of the technique of analgesia used. Pain will be assessed using the NS.
Postoperatively, PCA morphine pumps will be attached to patients. A loading dose of 0.05
mg/kg to a maximum of 5 mg will be administered in the Post Anesthesia Care unit (PACU) as
needed, followed by demand interval dosing of 0.015 mg/kg every 10 minutes.as demanded by the
patient .Four-hours limits for morphine will be set at 0.35 mg/kg. No continuous infusion and
no adjuvant NSAIDs or acetaminophen will be administered. Rescue morphine dosing will be
ordered via PCA pump at 0.05 mg/kg ( repeated once as needed) and will be available every two
hours as needed by pain assessment ( for a NS ≥ 4 ) or patient request. Diazepam 0.03 mg/kg
IV will be available every 4 to6 hours as needed for muscle spasm or anxiety. Patients will
be considered ready for discharge from hospital when all the following criteria are met:
Child is alert, oriented, stable vital signs, and would tolerate clear liquid, with no nausea
or vomiting and good pain control. The evaluation for meeting the discharge criteria will be
done after one hour from arrival in PACU and every 30 minutes thereafter till the patient
meet all the discharge criteria. After discharge, After discharge, parents will be instructed
to give the child oxycodone tablets/elixir 0.1 mg /kg PO q 3 hours as needed for pain. In
addition, acetaminophen 10mg/kg q 4 hours PRN and/or ibuprofen 10 mg/kg q 6 hours PRN up to
maximum of 2400 mg/24 hours, may be administered for any residual pain. The total dose of
oxycodone, ibuprofen and tylenol will be recorded per parents for a total of 24 hours after
PNB. Pain scores will be also recorded by parent at rest,24 hours post -block. The data for
total opioids use in the first 24 hours after PNB and Pain score at 24 hours will be
collected from parent by phone call.

- Study Endpoints

1-Quadriceps muscle strength pre-operatively and at 4 after PNB 2- Total
morphine/morphine equivalent at 4 and 24 hours after PNB. 3-Pain scores via NS at 4 and
24 hours after PNB.

- Method for Assigning Subjects to Treatment Regimen Random allocation for one of the two
treatments will be achieved using sealed envelope assigned by external third party not
involved in the study to ensure allocation concealment.

- Study Monitoring Plan This study will be monitored through a data monitoring committee.
The study will be performed over a period of 18-24 months. This study offers minimal
risk to the patient. The data monitoring committee will include the PI, at least one of
the co-investigators, the principal statistician, and the principal research nurse.

The data monitoring committee will meet when approximately 25%, 50%, 75% and 100% of the
primary outcomes are observed. The priority of the data monitoring committee will be to
ensure the safety of the participants in the trial and to ensure the integrity of the trial.
Also, these meetings will monitor the quality of the collected data to assess for weaknesses
and errors. If any weakness and/or errors are identified, feedback will be provided during
these meetings .The investigator(s) will allocate adequate time for such monitoring
activities. The investigator(s) will also ensure that the monitor or other compliance or
quality assurance reviewer is given access to all the above noted study-related documents.

-Summary Statistics: Will be provided for all variables. Examination of continuous data will
include normality testing as well as assessment of potential outliers. Statistical testing
will be based upon distributional shape, but for purpose of analytical planning and sample
size analysis normality of distributions will be assumed.

To examine for potential differences in quadriceps motor strength (QMS) between the two
groups (ACB, FNB), two change scores will be created and analyzed via T-Test for Equal and
Unequal Variances with appropriate Bonferroni adjusted alpha testing paired difference at two
distinctive time points. Assuming no statistically significant baseline differences between
the two groups the QMS Change scores will be a) Baseline to 4 hours. Sample size analysis
will be based upon testing of the QMS Change scores. Non-inferiority of ACB to FNB in
analgesia provided will be assessed by examination of pain scores. Non-inferiority of ACB
compared with FNB is defined as the mean ACB - NRS pain score not higher than the mean FNB -
NRS pain score by an amount of 1.6. (Kim, 2014) Pain scores will be individually examined at
the 4 hour and 24 hour post - operative time points with appropriate Bonferroni adjusted
alpha. In addition, a change in pain score from 4 to 24 hours will be created and evaluated
for potential difference between groups.

Total opioid consumption as measured in morphine equivalents will be assessed at the 24 hour
post-operative time point to determine whether a difference exists. Opioid consumption will
also be examined by creating a change score from 4 to 24 hour consumption and comparing
between the groups.

All testing will be completed utilizing SAS 9.4 © software and evaluated at the Type I Error
Rate of alpha = 0.05 level for statistical significance unless otherwise noted.

Inclusion Criteria:

- 1-ASA I or II 2- Age 8 to 18 years 3-All research subjects must have an acceptable
legally authorized representative capable of giving consent on the subject's behalf.

Exclusion Criteria:

- Those who were unable to use a standard 0-10 NS

- Infection at the site of the block

- Bleeding disorders

- Allergy to the drugs used to perform the block ( ropivacaine , methylprednisolone)

- Those who refused a nerve block or enrollment in the study.
We found this trial at
1
site
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-8823
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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mi
from
Akron, OH
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