Sciatic Peripheral Nerve Blockade for Pain Control Following Hamstring Autograft Harvest in Adolescents: A Comparison of Two Techniques
Phase: NA
Conditions: Anterior Cruciate Ligament (ACL) Tear
Sponsor: Children's Hospital Medical Center, Cincinnati

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Sciatic Peripheral Nerve Blockade for Pain Control Following 
Hamstring Autograft Harvest in Adolescents: A Comparison of Two 
Techniques 
 
 
 
CCHMC Protocol #: 
 
2014-6533 
 
Date:  
 
 
 
2014-10-01 
 
Principal Investigator: 
  
James Furstein, CRNA  
 
 
 
 
 
Staff CRNA 
Department of Anesthesiology 
 
 
 
 
 
Cincinnati Children’s Hospital Medical Center 
 
 
 
 
 
MLC 2001 
 
 
 
 
 
(513) 636-4408 
 
Co-Investigator(s):  
 
Marc Mecoli, MD 
 
Coordinator(s): 
 
 
Kristi Barnett 
 
 
 
 
 
Susan Glynn  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsor: 
 
 
 
AANA Foundation  
 
 
Device(s): 
 
 
 
None  
 
Anticipated Date(s): 
 
October 2014 – April 2017 
 
Approvals: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
 
 
ABSTRACT ................................................................................................................................................ iii 
BACKGROUND AND SIGNIFICANCE ........................................................................................... 1, 2, 3 
RESEARCH QUESTION ............................................................................................................................ 3 
PURPOSE OF THE STUDY ................................................................................................................. 3, 4 
PREVIOUS CLINICAL EXPERIENCE ..................................................................................................... 4 
STUDY DESIGN ..................................................................................................................................... 4, 5 
     Study Protocol................................................................................................................................. 5, 6 
          Sciatic Peripheral Nerve Blockade Description ......................................................... 6, 7, 8 
          Risk Benefit Analysis .................................................................................................................... 8 
     Subject Population ........................................................................................................................ 8, 9 
     Selection and Recruitment of Participants ............................................................................... 9 
          Preparation ............................................................................................................................... 9, 10 
          Vulnerable Populations ............................................................................................................ 10 
     Sample Size Determination .......................................................................................................... 10 
     Randomization ................................................................................................................................. 10 
     Components of Cincinnati Children’s Hospital Medical Center to be Utilized for 
     this Study ..................................................................................................................................... 10, 11 
     Data Collection ........................................................................................................................... 11, 12 
          Survey(s) and Questionnaire(s) ..................................................................................... 12, 13 
     Period of Time Estimated to Complete the Study ................................................................ 13 
DATA STORAGE AND STATISTICAL ANALYSIS ........................................................................... 13 
     Data Storage ............................................................................................................................... 13, 14 
     Primary Endpoint Analysis ................................................................................................... 14, 15 
DATA SAFETY AND MONITORING ............................................................................................ 15, 16 
     Adverse Event Definitions ............................................................................................................ 16 
     Adverse Event Reporting………………………………………………………….16 
     Data Safety Monitoring Plan………………………………………………………17 
     Data Safety Monitoring Committee ........................................................................................... 17 
PRIVACY AND CONFIDENTIALITY ............................................................................................ 17, 18 
FUNDING .................................................................................................................................................. 18 
COST AND PAYMENT FOR PARTICIPATION ................................................................................ 18 
THIS STUDY IS AFFILIATED WITH ANOTHER IRB-APPROVED STUDY .......18 
REFERENCE ...................................................................................................................................... 19, 20 
 

 
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Key Words: pain control, hamstring autograft, ACL, regional anesthesia, sciatic 
nerve 
 
ABSTRACT 
Anterior cruciate ligament reconstruction utilizing a hamstring autograft is a 
surgical technique that has gained popularity among orthopedic surgeons caring 
for adolescent patients.  While utilization of a hamstring autograft is a revered 
technique, harvest of the hamstring yields significant pain.  Sciatic peripheral 
nerve blockade has proven to reliably provide analgesia at the hamstring donor 
site.  Single-injection sciatic peripheral nerve blockade is considered a basic and 
effective technique, making its use following anterior cruciate ligament 
reconstruction standard practice in many institutions.  The duration of action of 
single-injection sciatic peripheral nerve blockade may fail to outlast the pain 
arising from the hamstring donor site, prompting some clinicians to employ 
continuous sciatic peripheral nerve blockade via an indwelling catheter.  A lack of 
comparative effectiveness studies exists in the literature regarding the duration of 
action of peripheral nerve blockade necessary to adequately provide pain control 
following hamstring autograft harvest, resulting in disagreement among clinicians 
as to best pain control practices.  Proponents of continuous sciatic peripheral 
nerve blockade assert that while more costly, the extended duration of analgesia 
afforded by this technique improves pain control postoperatively and decreases 
the use of other pain medications.  Advocates of single-injection sciatic 
peripheral nerve blockade cite concerns associated with continuous sciatic 
peripheral nerve blockade known to be detrimental to rehabilitation, such as 
decreased active knee flexion and increased risk of falls.  The purpose of this 
research is to compare the effect of single-injection sciatic PNB to continuous 
sciatic PNB on 1) postoperative pain control as measured by self-reported pain 
scores, pain medication use, and unplanned hospital admission due to poor pain 
control, 2) active knee flexion, and 3) patient satisfaction with pain control 
following ACL reconstruction with a hamstring autograft.  The findings of this 
study have the potential to guide informed clinical reasoning and decision making 
regarding sciatic peripheral nerve blockade techniques following hamstring 
autograft harvest in adolescents undergoing anterior cruciate ligament 
reconstruction.  
 

 
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I. 
BACKGROUND AND SIGNIFICANCE 
 
Anterior cruciate ligament (ACL) injury is the most prevalent injury treated in 
orthopedic sports medicine.  The incidence of ACL injuries continues to increase 
with approximately 250,000 now occurring annually in the United States 
(Gagnier, Morgenstern, & Chess, 2012).  As such, ACL reconstruction has 
become a common surgical procedure and is frequently performed on an 
outpatient basis.  ACL reconstruction has historically been avoided in skeletally 
immature patients due to concerns of injuring the immature physes, resulting in 
growth deformities.  Adolescents with ACL injuries were typically treated 
conservatively, with many orthopedic surgeons relying on non-surgical 
techniques, such as bracing and activity restrictions, for treatment.  Advances in 
surgical techniques, however, now allow ACL reconstruction to be performed 
safely and effectively in skeletally immature patients.  Subsequently, the 
incidence of ACL reconstruction in the adolescent population has increased 
approximately 300 percent in the last two decades.  
 
Currently the mean age of ACL reconstruction is 18 years indicating half of the 
number of patients undergoing ACL reconstruction are adolescents (Silvers & 
Mandelbaum, 2007).  Given the decreasing age of patients now undergoing this 
surgical procedure, orthopedic surgeons are charged with ensuring optimal ACL 
longevity following reconstruction.   
 
Several options exist for replacement of the damaged ligament during ACL 
reconstruction in adolescents, yet the use of a hamstring autograft has emerged 
as the technique of choice due to the overall decreased morbidity and proven 
long-term stability when compared to other ligament reconstruction options 
(Mehta, Mandala, Foster, & Petsche, 2010; Pallis, Svoboda, Cameron, & Owens 
2012). As such, there has been a marked increase in the use of hamstring 
autografts for reconstruction of the injured ACL in adolescents due to the 
favorable long-term outcome profile of this surgical technique when compared to 
other available graft reconstruction options.  The growing trend to use a 
hamstring autograft for ligament reconstruction is a departure from the technique 
typically employed in the adult population, where use of an allograft tendon, or 
transplant tendon from another individual, has been the predominant technique 
employed.  The use of hamstring autograft creates new concerns for surgeons 
and anesthetists alike, as this technique is known to lead to significant pain at the 
hamstring donor site during the postoperative period.  The significance of the 
pain secondary to hamstring autograft harvest remains undetermined beyond the 
initial 24 hours postoperatively, however, as it has yet to be fully investigated 
(Bushnell, Sakryd, & Noonan, 2010).  The harvesting of a hamstring autograft, 
however, yields significant postoperative pain for which no consensus exists 
among clinicians as to how to best treat. 
 
Sciatic peripheral nerve blockade (PNB) has proven to abate hamstring donor 
site pain in a reliable fashion while avoiding undesirable opioid-related side 

 
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effects (Bushnell, Sakryd, & Noonan, 2010).  The efficacy of sciatic PNB can be 
attributed to the origin of pain following hamstring autograft harvest, graft fixation, 
or both, which lies in the sciatic nerve distribution (Frost, Grossfeld, Kirkley, 
Litchfield, Fowler, & Amendola, 2000).  Controversy remains as to whether 
single-injection or continuous sciatic PNB is most appropriate following ACL 
reconstruction with a hamstring autograft.  Single-injection sciatic PNB is a 
regional anesthetic technique employed to anesthetize the sciatic nerve with a 
single dose of local anesthetic.  This technique offers pain control for a limited 
amount of time based on the volume and concentration of local anesthetic used.  
Continuous sciatic PNB entails placing a continuous perineural infusion (CPI) 
catheter so that local anesthetic may be released slowly but continuously 
adjacent to the sciatic nerve (perineural) for several days postoperatively.  While 
both techniques of sciatic PNB alleviate pain in the immediate postoperative 
period, only continuous PNB has the ability to reliably provide analgesia on 
subsequent postoperative days.  
 
No consensus exists regarding the duration of sciatic PNB necessary to 
effectively provide pain control following ACL reconstruction with a hamstring 
autograft.  The disagreement among clinicians as to best practices of pain control 
following ACL reconstruction with a hamstring autograft is largely due to the lack 
of evidence comparing single-injection and continuous sciatic PNB following 
hamstring autograft harvest. Mismanagement of pain can be detrimental, 
resulting in negative physiological, psychological, and economic consequences 
(Agin & Glass, 2005).  Failure to address pain may lead to future impairment in 
functioning as well as heighten anxiety and fear, which in turn may further 
increase the perception of pain (Matthews, 2011).  Continued mismanagement of 
pain results in increased suffering and misery that can ultimately impact one’s 
lifestyle and personality (Beales, Holt, Keen & Mellor, 1983).  In addition, 
unaddressed pain can cause great disruption to families caring for patients.  
From an economic perspective, the mismanagement of pain can lead to slower 
rates of recovery, resulting in increased healthcare-related costs and time away 
from school and work (Twycross, 2002).   
 
There is evidence that sciatic PNB, regardless of technique, significantly reduces 
pain when compared to intravenous opioids during the initial 24-hour 
postoperative period following knee surgery (Wegener, van Ooij, van Dijk, 
Hollmann, Preckel, & Stevens, 2011).  As such, single-injection sciatic PNB, 
which can last up to 24 hours, should provide adequate analgesia precluding the 
need for oral narcotic or nonsteroidal anti-inflammatory medications following 
ACL reconstruction with a hamstring autograft.  It remains unknown, however, if 
any benefit is gained during the initial 72-hour postoperative period from 
extending analgesia for the hamstring donor site via continuous sciatic PNB.  
While continuous sciatic PNB with a CPI catheter extends the duration of 
analgesia, it also extends the duration of anesthesia potentially leading to a 
decrease in motor function and subsequently active knee flexion.  The sciatic 
nerve innervates the hamstrings, which are responsible for knee flexion (Distad & 

 
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Weiss, 2013).  The decrease in active knee flexion may impede the ability of the 
patient to begin rehabilitation on the first postoperative day.  This is an important 
consideration because early rehabilitation, which includes contraction of the 
quadriceps and hamstring muscles as well as weight bearing exercises with the 
aid of crutches, leads to faster recovery of long-term range of motion and a lower 
incidence of knee laxity following ACL reconstruction when compared to delayed 
rehabilitation (Shaw, Williams, & Chipchase, 2005; Pinczewski et al., 2007).  
Determining the duration of sciatic PNB required to effectively control pain 
following ACL reconstruction with a hamstring autograft, without impeding active 
knee movement, will help define best practice going forward. 
 
 
II. 
RESEARCH QUESTION 
 
This study aims to answer the following research question: Does the duration of 
sciatic PNB impact the ability to effectively provide postoperative pain control 
following ACL reconstruction with a hamstring autograft in the adolescent 
population?  
 
 
III. 
PURPOSE OF THE STUDY 
 
The purpose of this research is to compare the effect of single-injection sciatic 
PNB to continuous sciatic PNB on 1) postoperative pain control as measured by 
self-reported pain scores, pain medication use, and unplanned hospital 
admission due to poor pain control, 2) active knee flexion, and 3) patient 
satisfaction with pain control following ACL reconstruction with a hamstring 
autograft.  The results of this research have the potential to positively impact pain 
control for the adolescent population undergoing this surgical procedure and 
foster responsible utilization of limited resources.   
 
SPECIFIC AIM 1.  The first aim of the study is to explore the impact of 
sciatic PNB technique on hamstring donor site pain control postoperatively.  
H1.a.  The extended duration of analgesia offered by continuous sciatic 
PNB decreases pain scores during the initial 72 hours following hamstring 
autograft harvest when compared to single-injection sciatic PNB.  
H1.b.  The extended duration of analgesia offered by continuous sciatic 
PNB decreases oral pain medication use during the initial 72 hours following 
hamstring autograft harvest when compared to single-injection sciatic PNB.  
H1.c.  The extended duration of analgesia offered by continuous sciatic 
PNB decreases the incidence of unplanned admission due to poor pain control 
during the initial 72 hours following hamstring autograft harvest when compared 
to single-injection sciatic PNB.  
 
SPECIFIC AIM 2.  The second aim of the study is to explore the impact of 
sciatic PNB technique on active knee flexion postoperatively.  

 
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H2.  The extended duration of analgesia offered by continuous sciatic 
PNB does not delay active knee flexion during the initial 72 hours following 
hamstring autograft harvest when compared to single-injection sciatic PNB.  
 
SPECIFIC AIM 3.  The third aim of the study is to explore the impact of 
sciatic PNB technique on patient satisfaction with postoperative pain control.  
H3.1.  The extended duration of analgesia offered by continuous sciatic 
PNB improves patient satisfaction during the initial 72 hours following hamstring 
autograft harvest when compared to single-injection sciatic PNB. 
 
 
IV.    PREVIOUS CLINICAL EXPERIENCE 
 
Concurrent Research Studies:  The Department of Anesthesiology is not 
currently conducting another protocol with this patient population.  
 
By the Investigator:  This investigator currently is conducting research regarding 
the efficacy of regional anesthetic techniques at Cincinnati Children’s Hospital 
Medical Center (CCHMC).  Recruitment for an IRB-approved study comparing 
the efficacy of ultrasound-guided transversus abdominis plane blockade with 
surgeon performed ilioinguial/iliohypogastric blockade following unilateral inguinal 
herniorrhaphy is on-going.   
 
By Other Investigators:  Sciatic PNB has been reported to most reliably decrease 
hamstring donor site pain, however, there remains no consensus as to the 
duration of action required to effectively control donor site pain throughout the 
postoperative period (Tran, Ganley, Wells, Ganesh, Minger, & Cucchiaro, 2005; 
Bushnell, Sakryd, & Noonan, 2010).  
 
To date, there has only been one study reported in the literature comparing 
single-injection and continuous sciatic PNB. Continuous sciatic PNB was 
reported to offer significant advantages in pain control for adults only during the 
initial 24 hours following knee surgery (Wegener, van Ooij, van Dijk, Hollmann, 
Preckel, & Stevens 2011).  It should be noted, however, this study does not refer 
to ACL reconstruction, rather the study population is comprised of patients 
undergoing total knee replacement making it challenging to appropriately 
translate and apply the clinical knowledge gained from that study to other clinical 
scenarios.   
 
 
V.     STUDY DESIGN 
 
This study employs an experimental posttest-only design with repeated follow-up, 
with the gate control theory of pain serving as the theoretical foundation. An 
experimental posttest-only design with repeated follow-up is appropriate for this 
study, as the outcome is not relevant until after the intervention is complete. This 

 
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study is a randomized prospective observational study to compare the effect of 
single-injection sciatic PNB to continuous sciatic PNB on postoperative pain 
control, active knee flexion, and patient satisfaction with pain control following 
ACL reconstruction with a hamstring autograft.   
 
A. Study Protocol:   
The intervention in this study will be one of two techniques for sciatic PNB: 
single-injection PNB or continuous sciatic PNB with a CPI catheter.  The PNB 
protocol will be assigned by computer-generated randomization.  All study 
participants will receive standard care, including standard anesthetic care as 
recommended by the American Society of Anesthesiologists and the 
American Association of Nurse Anesthetists, and the surgical procedures will 
be in accordance with those set forth by the American College of Surgeons.  
Anesthetic management will be left to the discretion of the clinical team 
providing anesthesia care, which includes, but is not limited to, the amount of 
inhalation anesthetic and intravenous opioids each study participant receives 
throughout the intraoperative portion of the study.  
All sciatic PNB will be performed following the induction of general 
anesthesia, but prior to the end of anesthesia. For patients randomized to the 
single-injection sciatic PNB group, ultrasound will be utilized to identify the 
sciatic nerve in the sub-gluteal region.  Once the sciatic nerve is identified, 1 
mL/kg (to a maximum volume of 20 mLs) of 0.2% ropivacaine without 
epinephrine will be injected into the perineural space surrounding the sciatic 
nerve.   
 
For patients randomized to the continuous sciatic PNB group, ultrasound will 
be utilized to assist the anesthesia team with placing the catheter tip adjacent 
to the sciatic nerve in the sub-gluteal region in preparation for continuous 
infusion of local anesthetic postoperatively. Once proper placement of the 
sciatic CPI catheter is verified, 1 mL/kg (to a maximum volume of 20 mLs) of 
0.2% ropivacaine without epinephrine will be administered incrementally over 
two minutes.  An infusion of 0.125% ropivacaine will be started at the end of 
surgery at a rate of 3-4 mL/hr (based on patient weight) for 48 hours 
postoperatively. While assessments will be made through 72 hours 
postoperatively, CPI catheters will only remain in-situ for 48 hours, as the 
incidence of infection increases should an indwelling CPI catheter remain 
greater than 48 hours (Jeng, Torrillo, & Rosenblatt, 2010). 
 
Following sciatic PNB, continuous femoral PNB will be performed.  Patients in 
both study groups will receive continuous femoral PNB with a CPI catheter to 
provide analgesia to the anterior aspect of the knee, as this is an accepted 
standard of practice following ACL reconstruction. Ultrasound will be utilized 
to assist the anesthesia team with placing the catheter tip adjacent to the 
femoral nerve in the inguinal region in preparation for continuous infusion of 

 
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local anesthetic postoperatively.  Once proper placement of the femoral CPI 
catheter is verified, 1 mL/kg (to a maximum volume of 20 mLs) of 0.2% 
ropivacaine without epinephrine will be administered incrementally over two 
minutes.  An infusion of 0.125% ropivacaine will be started at the end of 
surgery at a rate of 6-8 mL/hr (based on patient weight) for 48 hours 
postoperatively.  
 
The recommended dosing range of ropivacaine is 0.2-0.4 mg/kg/hr (Chelly, 
2009).  Therefore, patients weighing 60 kg or more will receive infusions of 
0.125% ropivacaine at a rate of 8 mL/hr via the femoral CPI catheters and a 
0.125% ropivacaine at a rate of 4 mL/hr via the sciatic CPI catheter (as 
applicable).  Patients weighing less than 60 kg will receive an infusion of 
0.125% ropivacaine at 6 mL/hr via the femoral CPI catheter and 3 mL/hr via 
the sciatic CPI catheter (as applicable).  These parameters ensure that the 
total local anesthetic dose remains within the recommended dosing 
guidelines should a patient be randomized to receive both continuous femoral 
PNB and continuous sciatic PNB.  In addition, establishing weight based 
infusion rates allows for the study group receiving one CPI catheter and the 
group receiving two CPI catheters to be as similar as possible thereby 
improving the ability to compare the outcomes of each study group.  
 
Patients will not be blinded as to what study group they have been 
randomized to participate in.  Blinding of subjects can be beneficial in studies 
because it minimizes the introduction of biases stemming from awareness.  
Blinding is not always possible, however.  For example, in this study it would 
be challenging to blind subjects to the sciatic nerve block treatment group, as 
one group will have an indwelling sciatic CPI catheter and the other will not.  
One means of blinding study participants would be to insert sciatic CPI 
catheters in all patients and infuse local anesthetic in one group and a 
placebo in the other group, however, the costs and potential risks, such as 
opportunity for infection, potential tissue damage and potential for abscess 
formation secondary to infusion of a placebo, makes blinding of study 
participants prohibitive.   
 
1. Sciatic Peripheral Nerve Blockade Description: 
Under ultrasound-guidance, the sciatic nerve can readily be identified in 
the posterior thigh.  The nerve appears hyperechoic and can be traced 
distally to the popliteal fossa, where it divides into the tibial and common 
peroneal nerves.  Local anesthesia is injected under real-time visualization 
following a negative aspiration.  If a single-injection block is done, local 
anesthesia is deposited adjacent to the sciatic nerve within the fascial 
plane, but not within the epineurium.  Should a CPI catheter be placed, the 
CPI catheter will be placed under ultra-sound guidance, with the tip of the 
catheter being placed immediately adjacent to the sciatic nerve, after the 
local anesthesia has been deposited.  
 

 
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Peripheral Nerve Blockade Related Risks:  While the general risks for 
peripheral nerve blockade apply to femoral and sciatic nerve blockade, the 
site of injection for these blocks is considered relatively low risk.  The risks 
of the drug in the current study are no different than would be expected 
when the drug is used in any other local infusion.  As with any local 
anesthetic drug, high doses or unintentional intravascular injection may 
lead to high plasma levels and related myocardial depression, decreased 
cardiac output, heart block, hypotension, bradycardia, ventricular 
arrhythmias, including ventricular tachycardia and ventricular fibrillation, 
and possibly cardiac arrest. 
 
 
Risks related to the drug utilized in the current study ropivacaine are 
characteristic of those associated with other amide-type local anesthetic 
drugs, which include: 
 
 Uticaria 
 Pruritus 
 Erythema 
 Angioneurotic edema 
 Tachycardia 
 Sneezing 
 Nausea 
 Vomiting 
 Elevated temperature 
 Possibly anaphylactoid symptomology 
 
Additionally, there is a low risk of mild discomfort or inconvenience to the 
subject, as they will receive regional blockade of some nature.  
Additionally, unforeseen risks may include, but are not limited to: 
 
 Needle trauma 
 Intraneural injection 
 Intravascular injection 
 Local anesthetic toxicity 
 Hematoma 
 Infection  
 Poor/failed block 
 
Finally, risks related to the use of a CPI catheter are rare, but include: 
 
 Infection 
 Infusion pump malfunction 
 Local anesthetic toxicity 
 Skin irritation or allergic reaction secondary to dressing material 
 Unintentional CPI catheter dislodgement  

 
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 Fluid (local anesthetic) leakage at the CPI catheter insertion site 
 Falls secondary to motor blockade 
 
2. Risk Benefit Analysis:  
Benefits:  Subjects in this research study are unlikely to gain any personal 
benefit on the day of the study from their participation as the decisions of 
the clinical team caring for the patients will be guided by the randomized 
study protocol. The knowledge gained may be of benefit in the 
management 
of 
future 
adolescent 
patients 
who 
require 
ACL 
reconstruction. The ability to effectively provide pain control will lead to 
more efficient utilization of healthcare resources.  
 
Study Related Risks:  The risks associated with this study are minimal and 
are related to PNB.  Both techniques of sciatic PNB included in this study 
are accepted techniques in clinical practice.  All risks related to sciatic 
PNB are incidental, that is, associated with PNB, not the study itself as 
this is an observational study.    
 
Risks/Benefit Analysis:  It is the opinion of the principal investigator (PI) 
that this study is classified as “minimal risk but without direct benefit to 
participants”.   
  
B. Subject Population: 
 
A subject may be INCLUDED in this study if: 
1. The subject is male or female; 
2. The subject is of any racial or ethnic group;  
3. The subject is age 10 years to 18 years (inclusive); 
4. The subject is scheduled for the following: 
Unilateral ACL reconstruction with a hamstring autograft under general 
anesthesia on an outpatient basis, and not being performed in 
conjunction with any other surgical procedures; 
5. The subject is American Society of Anesthesiologists (ASA) patient 
      classification I-II; 
6. The subject or legally authorized representative has consented to  
femoral and sciatic peripheral nerve blockade for the procedure and 
the consent for peripheral nerve blockade has been obtained by a 
clinician (MD, DO, CRNA or APRN) authorized to obtain consent;  
7. The subject’s legally authorized representative has given written  
      informed consent to participate in the study and when appropriate, the 
      subject has given assent or consent to participate. 
 
A subject will be EXCLUDED from this study if:  
1. Additional surgical procedures are being performed concurrently; 
2. The subject is ASA classification > II; 
3. The subject has pre-existing allergies to amide local anesthetics;  

 
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4. The subject is schedule for overnight hospital admission; 
5. The subject has any other condition, which in the opinion of the 
principal investigator, would not be suitable for participation in the 
study, including but not limited to coagulopathy, preexisting central or 
peripheral nervous systems disorders, and local infection or sores at 
the anticipated site of needle insertion; 
6. Unsuccessful PNB or CPI catheter placement occurs during the study. 
 
In addition, patients undergoing ACL reconstruction under the care of Dr. 
Charles Mehlman at CCHMC will be recruited for comparative analysis.  
Currently, Dr. Mehlman is the only Orthopedic Surgeon at CCHMC who does 
not allow his patients to receive peripheral nerve blockade following ACL 
reconstruction with hamstring autograft.  Following his patients for 72 hours 
postoperatively with the same data collection tool used for the other patients 
enrolled in this study would provide a benchmark for comparison. There 
would be interventions for his patients, as their participation is purely 
observational in nature. 
 
C. Selection and Recruitment of Participants: 
The PI will work closely with the research coordinator and the co-investigators 
to screen and identify appropriate subjects listed on the daily operating room 
schedule at the Liberty Campus of CCHMC according to the inclusion and 
exclusion criteria defined in the study protocol.  Once a potential subject is 
identified, either the PI or the research coordinator will discuss the purpose 
and procedures of the study with the patient and his or her guardian(s).  
Hospital-approved interpreters will be utilized for non-English speaking 
patients and/or guardian(s).  Participants and their guardians will be informed 
of the voluntary nature of participation and the ability to drop out of the study 
at any time without negative consequences.  If the guardian(s) express 
interest in participating in the study, they will be asked to read the written 
informed consent.  When appropriate, assent or consent to participate will be 
obtained from the patient.  Written assent will be obtained from the patient if 
the patient is  11 years of age and is able to provide written assent, which 
represents standard policy with regards to age of assent at CCHMC. 
  
To allow for the broadest application of clinical outcomes, enrolled subjects 
will vary in their physical characteristics to the greatest extent possible given 
the inclusion and exclusion criteria.   
 
1.   Preparation: 
Following identification of a potential subject, the patient and/or his/her 
parent(s)/guardian(s) may be called prior to scheduled surgery to initiate 
the informed consent process and to determine family interest in 
participation.  If the patient and/or guardian(s) express interest during the 
phone call and the patient qualifies for the study, the family will be 
approached in Same Day Surgery by one of the study team members to 

 
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complete the informed consent process.  Once all questions have been 
answered and the informed consent signed, the patient will be enrolled in 
the study at which time the subject will be assigned a study identification 
number.  Written assent will be obtained if the child is  11 years of age 
and is able to provide written assent.   
 
2.   Vulnerable Populations: 
Children from 10 years to 18 years of age (inclusive) will be recruited for 
this study after obtaining written informed consent from their parents and 
assent when appropriate (age >11 years).   
 
D. Sample Size Determination:  
Power analysis was performed to estimate an adequate sample size to 
support statistical conclusion validity and so that correct inferences can be 
made about the relationships between study variables.  The standardized 
effect size was calculated to equal 0.5.  Assuming an alpha of 0.05, power of 
0.80 and a standardized effect size of 0.5, 64 patients will be required for 
each treatment group based on anticipated difference in patient reported pain 
scores due to sciatic PNB technique.  Projected sample sizes were increased 
approximately ten percent from 64 per group to total of 70 subjects per group 
in an effort to account for patient attrition and lost data, therefore, a total of 
140 patients will be enrolled in the study.  Additionally, if the loss in patients is 
unequal between groups, yielding a significant disparity between study group 
composition, additional subjects may be added to account for this unequal 
loss.  
 
Despite the presence of multiple cofounding variables, the calculated sample 
size is sufficient to determine if a significant difference in outcomes measures 
exists secondary to sciatic PNB technique.  Additionally, the sample size does 
not need to be altered based on the equation: N > 50 +8k, where N is the 
number of cases and k is the number of predictors (Warner, 2013).  In this 
study there is only one predictor, sciatic PNB technique, which is anticipated 
to impact outcomes following ACL reconstruction.  
 
     E.  Randomization: 
A computer generated randomization scheme will be used to assign 70 
patients to each treatment group.  The randomization will be done using the 
maximum allowable percent deviation method.  This algorithm conducts a 
search to find a randomization list for which all percent deviations are less 
than or equal to the maximum allowable percent deviation of 10%.  The 
randomization scheme will be sent to the PI who will then prepare and 
maintain a log of subject assignments.  The PI will notify the participating 
surgeon and anesthesia team of the treatment (single-injection or continuous 
sciatic PNB) that is to be given to the next consented patient.  The research 
coordinator will remain blinded to the assigned treatment plan until data 
collection has been completed.    

 
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F. Components of Cincinnati Children’s Hospital Medical Center to be  
    Utilized for this Study: 
Subjects undergoing unilateral ACL reconstruction with a hamstring autograft 
on an outpatient basis at the Liberty Campus of CCHMC will be recruited from 
the OR schedule.  
 
G: Data Collection:  
Participants will be in the research study for approximately 4 days; the day of 
surgery and for follow-up phone calls once a day for the first three days after 
surgery. A minimum of three phone calls may be made after the patient is 
discharged. Once enrolled in the study, a unique study identification number 
will be assigned to each study participant.  Assigning a unique patient 
identifier to each study participant allows any data gathered pertaining to 
them to be attached to this number rather than any patient identifiers, further 
ensuring that a breach in confidentiality does not occur (Polit & Beck, 2012).  
After obtaining written consent from the guardian(s), the medical record of the 
patient will be reviewed for further inclusion and exclusion criteria.  
 
All data gathered will be used specifically for research purposes.  Data 
collected preoperatively will include age, gender, BMI, ASA physical status, 
previous surgical history, self-reported tolerance of pain, self-reported level of 
activity since time of ACL injury, and the name of the orthopedic surgeon 
scheduled to perform ACL reconstruction.  In addition, several questions 
regarding the patient’s anxiety level will be asked to determine whether or not 
the patient has a history of anxiety that may impact pain and/or satisfaction 
scores postoperatively (see Appendix A).  This data will be collected from the 
patent’s medical record during the preoperative phase and directly from the 
patient and/or guardian(s) when appropriate.  Data on study group 
assignment, analgesic requirement, the length of surgery, length of pneumatic 
tourniquet inflation time, pneumatic tourniquet inflation pressure, and systolic 
blood pressure at time of pneumatic tourniquet inflation will be gathered 
during the intraoperative phase.   
 
In an effort to discern the impact of sciatic PNB technique on the outcome 
measures, data on self-reported pain scores, doses of oral pain medications, 
unplanned admission to the hospital due to poor pain control, and patient 
satisfaction will be gathered while the patient remains in the post anesthesia 
care unit (PACU). Data collection will then continue for 72 hours 
postoperatively following discharge from the PACU.  Patients will document 
data measures on supplied data collection instruments (see Appendix B).   
 
The patient or their guardian will record pain scores once every 6 hours for 72 
hours postoperatively.  In addition, the patient or their guardian will note the 

 
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date and time their leg was no longer numb behind their knee.  The 
orthopedic surgeon performing the ACL reconstruction or a member of his 
orthopedic team will prescribe all postoperative oral pain medication.  The 
oral pain medication typically prescribed is either Percocet or Vicodin.  
Vicodin, a schedule 3 controlled substance, is approximately half as potent as 
Percocet, which is a schedule 2 controlled substance.  The patient will record 
the time and dose of all oral pain medication taken during the 72 hours 
postoperative period.  The patient or their guardian will also record data 
regarding pain associated with active knee flexion once every 12 hours for 72 
hours postoperatively.  In addition, the patient or their guardian will record 
satisfaction with pain control once every 12 hours for 72 hours 
postoperatively. 
 
The research coordinator may collect all data recorded by the patient and/or 
their guardian via telephone interview.  Data will be collected using the same 
data collection tool given to the study participants to avoid instrumentation 
and maintain interrater reliability.  Untoward events, such as unplanned 
hospital admission, CPI catheter dislodgement, or local anesthetic toxicity, will 
also be noted should they occur.  This information will be collected from the 
patient or guardian once every 24 hours by the research coordinator during 
the 72-hour postoperative period; the postoperative period begins at the time 
of discharge from the PACU.   
 
 
1.  Survey(s) and Questionnaire(s):     
Patients and their guardian will be given data collection instruments 
to complete postoperatively at the time of enrollment to facilitate 
recall when conveying information to the study staff during 
telephone conversations.  The data collection instruments will be 
available in different languages and utilized for non-English 
speaking patients and/or guardians.  The patient and their 
guardian(s) will receive training regarding the data collection tool 
both during the time of enrollment and again prior to discharge from 
the hospital.  At the time of enrollment, essential phone numbers, 
including home phone and cell phone numbers, will be collected.  
Should the patient and/or guardian lose the data collection sheet, 
additional copies can be emailed to them upon request.  Hospital-
approved interpreters will be utilized for non-English speaking 
patients and/or guardian(s).  
 
The goal of the data collection tool is to promote accurate data 
recording, limit the likelihood of missing information, and to promote 
efficient and accurate data entry into REDCapTM.  Prior to the start 
of study enrollment, the data collection tool will be piloted in an 
effort to reduce error in the measurement process.  Five volunteers 
undergoing ACL reconstruction with a hamstring autograft at the 

 
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Liberty Campus of CCHMC will be sought out to trial the data 
collection tool.  Refinement of the data collection tool will center on 
reliability and validity of the tool.  Focusing on stability, internal 
consistency, and interrater reliability during the pilot of the tool will 
allow for estimates of the tool’s reliability.  Stability, or test-retest 
reliability, is determined by administering the tool two different times 
to the same individuals and determining the correlation between the 
two sets of scores (Kimberlin & Winterstein, 2008).  Cronbach’s 
alpha, which is a function of the average intercorrelations of items 
and the number of items in the scale, is the most widely used 
method for estimating internal consistency (Kimberlin & Winterstein, 
2008).   Interrater reliability requires completely independent ratings 
of the same event by more than one individual (Kimberlin & 
Winterstein, 2008).  Tests of the tool’s validity will focus on 
construct validity, content validity, and criterion-related validity.  
Evaluation of construct validity requires an examination of the 
relationship between the outcome measures being evaluated and 
variables related to the construct being measured by the instrument 
(Kimberlin & Winterstein, 2008).  As there is no statistical test to 
determine whether a measure adequately represents a construct, 
content validity typically relies upon the judgment of experts in the 
field (Kimberlin & Winterstein, 2008).  Assessment of criterion-
related validity will focus on the tool’s ability to accurately predict 
how well the scores of a given measure correlate with the scores of 
the other measures of the same construct.  Revisions will be made 
to the data collection tool as necessary prior to the start of the 
study.  
 
 
H.  Period of Time Estimated to Complete the Study:  
Each enrollment will take variable time to complete depending on the length 
of the surgical procedure and amount of time required in the recovery room.  
Following enrollment, data is collected for 72 hours postoperatively.  The 
entire study will take approximately 2 years to enroll and complete. 
 
 
VI.   DATA STORAGE AND STATISTICAL ANALYSIS 
 
A.  Data Storage: 
Data confidentiality will be maintained by data being stored in a password 
protected computer and hard copies of subject information stored in a locked 
office.  All data is collected from the study participant will be entered into 
REDCapTM (Park City, Utah) by the research coordinator.  REDCapTM is a 
secure web application for building and managing databases securely that 
was specifically designed to support clinical and translational research 

 
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(Harris, Taylor, Thielke, Payne, Gonzalez, & Conde, 2009).  Confidentiality of 
the data will be maintained through the use of a password-protected 
computer and any hard copies of subject information stored in a locked office 
accessible only to members of the Department of Anesthesia.   
 
The study records will be made available for review only to the Institutional 
Review Board and the Food and Drug Administration (FDA) per CCHMC 
policy.  The FDA is a branch of the federal government that establishes 
regulations and guidelines for clinical research to protect participants from 
unreasonable risks.  Furthermore, the FDA ensures consumers have reliable 
information and that medical treatments are not only safe, but effective as 
well.  The subjects’ names or any other identifiers will not be used in 
published information relating to this study and will be treated as confidential 
per the Health Insurance Portability and Accountability ACT (HIPAA) of 1996.  
Per the HIPAA Privacy Rule, prior to dissemination of results, all health 
information will be deemed individually unidentifiable by employing the 
approved Safe Harbor method of de-identification that entails the removal of 
18 types of identifiers.   
 
B. Primary Endpoint Analysis:  
The hypothesis that the extended duration of analgesia offered by continuous 
sciatic PNB decreases pain scores during the initial 72 hours following 
hamstring autograft harvest when compared to single-injection sciatic PNB 
will be tested with two separate tests.  Both Pearson’s correlation and the 
Wilcoxon Mann Whitney test will be utilized to test his hypothesis, as 
controversy surrounds the analysis of Likert scale data.  It has been argued 
that only nonparametric statistics should be used on Likert scale data, as the 
intervals between the scale values may not be equal (Jamison, 2004).  Taking 
this into consideration, the pain scores recorded for each patient will be 
totaled and an average pain score will be calculated for each study 
participant.  This will allow the data to be measured on a continuous scale, 
thereby meeting the criteria of Pearson’s correlation.  Pearson’s correlation is 
a parametric test that measures the degree and direction of linear relationship 
between two variables (Gravetter & Wallnau, 2000).  The Wilcoxon Mann 
Whitney test will also be used to analyze pain scores recorded at each 12-
hour period to determine if there is a difference in outcomes related to the 
duration of analgesia provided by sciatic PNB technique.  This test is 
appropriate when there is one IV with two independent groups and the DV is 
ordinal in nature.  The Wilcoxon Mann Whitney test is a nonparametric test of 
the null hypothesis that two populations are the same against an alternative 
hypothesis.  This test uses the relative position of the data in a rank ordering, 
rather than the actual values.  Using both parametric and nonparametric tests 
will increase confidence when drawing conclusions should both tests lead to 
the same results. 
 

 
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The hypothesis that the extended duration of analgesia offered by continuous 
sciatic PNB decreases oral pain medication use during the initial 72 hours 
following hamstring autograft harvest when compared to single-injection 
sciatic PNB will be tested with the Independent Samples t-Test.  The 
Independent Samples t-Test is appropriate when there is on IV with two 
independent groups and the DV is continuous in nature (Field, 2009).  The 
Independent Samples t-Test is used to compare differences between 
separate groups when there are two experimental groups (single-injection 
sciatic PNB and continuous sciatic PNB) and different study participants have 
been used in each group (Field, 2009).   
 
The hypothesis that the extended duration of analgesia offered by continuous 
sciatic PNB decreases the incidence of unplanned admission due to poor 
pain control during the initial 72 hours following hamstring autograft harvest 
when compared to single-injection sciatic PNB will be tested with the Chi-
square test.  The Chi-square test is used to determine if there is a relationship 
between two categorical variables (Field, 2009).  As the data for this DV are 
categorical, the focus during analysis is placed on frequencies rather than 
means.  The Chi-square test can be used to determine if there is a significant 
difference between the expected frequencies and observed frequencies in 
one or more categories (Field, 2009). 
 
The hypothesis that the extended duration of analgesia offered by 
continuous sciatic PNB does not delay active knee flexion during the initial 
72 hours following hamstring autograft harvest when compared to single-
injection sciatic PNB will be tested using the Wilcoxon Mann Whitney test.  
The hypothesis that the extended duration of analgesia offered by 
continuous sciatic PNB improves patient satisfaction during the initial 72 
hours following hamstring autograft harvest when compared to single-
injection sciatic PNB will also be tested using the Wilcoxon Mann Whitney 
test.  The Wilcoxon Mann Whitney test is appropriate to test both these 
hypotheses, as this test is designed to evaluate the difference between two 
treatments (single-injection sciatic PNB and continuous sciatic PNB) using 
data from an independent measures study (Gravetter & Wallnau, 2000).  
During analyses, testing may be altered based on the recommendations of 
the statistician to better analyze the collected data.  Intention-to-treat 
analysis will not be employed, as this may skew results and it is often difficult 
to obtain outcome data for study participants who have dropped out of the 
study (Polit & Beck, 2012).   
 
Prior to any analyses, the distribution of the demographic variables will be 
compared between the two treatment groups.   All statistical tests will be two-
sided with a significance level of α=0.05 and will be conducted using SAS® 
software, (Version 9.2, Cary, NC). Following the enrollment of the initial 30 
subjects (with 15 in each study group), an interim analysis utilizing the 
statistical tests later described will be performed to determine if statistically 

 
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significant differences exist between the outcome measures of each sciatic 
PNB technique.  Performing an interim analysis limits the number of patients 
exposed to study procedures.  If statistically significant differences exist such 
that one of the two sciatic PNB techniques clearly produces superior patient 
outcomes, the study will be stopped.  However, should the outcomes 
measures of each sciatic PNB technique be found to be equivalent and 
without statistically significant differences enrollment will continue.   
 
 
VII.   DATA SAFETY AND MONITORING 
 
Adverse events will be collected until data collection is complete.  Adverse 
events will be recorded on the case report forms.  Details will include an 
explanation of the event, seriousness, anticipation, treatment, resolution and 
relatedness to the study treatment.  All study-related adverse events will be 
followed through to completion 
 
A.  Adverse Event Definitions: 
The definitions for adverse event, adverse device effect, serious adverse 
event, serious adverse device effect, and unanticipated adverse device effect 
are provided below (ANSI/AAMI/ISO 14155-2:2003, 21 CFR 812.3(s)). 
 
Adverse Event: an adverse event is any untoward medical occurrence in a 
subject, which need not be related to the treatment under investigation. 
 
Adverse Peripheral Nerve Blockade Blockade Effect: an adverse peripheral 
nerve blockade effect is any untoward or unintended response to regional 
blockade, which may result from insufficiencies in the deployment of the 
ultrasound machine, or from provider error. 
 
Serious Adverse Event: a serious adverse event is an adverse event that 
results in death, inpatient hospitalization, severe or permanent disability, a life 
threatening illness or injury, fetal distress, fetal death, a congenital 
abnormality, a birth defect, or medical or surgical intervention to prevent 
permanent impairment to body or structure. 
 
Serious Adverse Peripheral Nerve Blockade Effect: a serious adverse 
peripheral nerve blockade effect is an adverse regional blockade effect that 
results in death, inpatient hospitalization, and severe or permanent disability 
or is life threatening. 
 
Unanticipated Peripheral Nerve Blockade Effect: any serious adverse effect 
on health or safety or any life threatening problem or death caused by, or 
associated with, peripheral nerve blockade if the effect, problem, or death 
was not previously identified in nature, severity or degree of incidence in the 

 
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investigational plan, or application (including a supplementary plan or 
application) or any other unanticipated serious problem associated with 
peripheral nerve blockade that related to the rights, safety or welfare of 
subjects.  Refer to the Peripheral Nerve Blockade Risk Analysis and Risk 
Assessment section for details on anticipated adverse regional blockade 
effects.  
 
B.  Adverse Event Reporting: 
All serious adverse events will be reported to the IRB per IRB reporting 
requirements.  These reports may include, but will not be limited to: date of 
onset; brief description of the events; their treatment; whether they resulted in 
death, inpatient hospitalization, severe or permanent disability or were life 
threatening; their relationship to the study device; and resolution.  All 
unanticipated adverse device effects will be reported to the IRB.   
 
C. Data Safety Monitoring Plan: 
In an effort to ensure patient safety throughout the course of this study, a 
Data Safety Monitoring Plan has been established. The Data Safety 
Monitoring Committee shall convene at predetermined intervals to assess the 
progress of the study for potential patient-related adverse events. Such 
events include, but are not limited to: infection at the CPI catheter insertion 
site, infusion pump malfunction, local anesthetic toxicity, skin irritation or 
allergic reaction secondary to CPI catheter dressings, and falls secondary to 
motor blockade. Should 2 or more study-related adverse events occur, the 
study will be suspended immediately pending review of the study and results 
to date by the Data Safety Monitoring Committee. In addition, should any 
unforeseen study-related adverse event not previously reported in the 
literature occur, the study will be stopped for review by the Data Safety 
Monitoring Committee. Should the study be stopped at any point, enrollment 
will not resume until the Data Safety Monitoring Committee has determined 
that it is safe to resume the study.  In addition, at any point during the course 
of the study should the Data Safety Monitoring Committee determine that it is 
not in the best interest of adolescent patients undergoing ACL with a 
hamstring autograft to continue the study, the study will be stopped. 
 
D. Data Safety Monitoring Committee: 
The Data Safety Monitoring Committee will meet to review the results of the 
study to date following the enrollment of the 30 participants, 60 participants, 
and 90 participants.  In addition, the Data Safety Committee shall convene if 2 
or more study-related adverse events occur related to this study. The Data 
Safety Monitoring Committee shall be comprised of 2 members of the 
Department of Anesthesia credentialed by CCHMC to perform peripheral 
nerve blockade but who are not part of this study (Dr. Vidya Chidambaran 
and Dr. Nancy Samol), a statistician, and a patient advocate. The patient 
advocate will be the parent of a patient who has previously undergone ACL 
reconstruction at the Liberty Campus of CCHMC.  

 
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VIII. PRIVACY AND CONFIDENTIALITY 
 
All subjects screened and enrolled in this study will be identified only by their 
initials and/or assigned study number only. Data confidentiality will be maintained 
by data being stored in a password protected computer and hard copies of 
subject information stored in a locked office. All information collected will be 
treated as confidential, as provided by law.  The study records will be made 
available for review only to the Institutional Review Board (IRB) and the Food 
and Drug Administration (FDA).  The subjects’ names or any identifier will not be 
used in published information relating to this study. 
 
IX.  FUNDING 
 
This is a CCHMC investigator initiated study that has received financial support 
from the AANA Foundation. 
 
X.  COST AND PAYMENT FOR PARTICIPATION 
 
The patient's insurance company will be charged for all PNB and associated 
equipment utilized in this observational study. This is not a departure from 
standard practice of care, as PNB is routinely employed for postoperative pain 
control following ACL reconstruction with a hamstring autograft in the adolescent 
population. 
 
Patients undergoing surgery with Dr. Mehlman will not receive any charges 
related to PNB as they will not receive PNB per his discretion. 
 
The patient's insurance company may be charged for continuing medical care 
and/or hospitalization including tests and treatments of any side effects of the 
study treatment that may occur.  In the event that the insurance does not cover 
all costs, patients may incur additional costs because of treatment side effects. 
 
A $20.00 gift card will be distributed as incentive to all participants who enroll in 
this study. The gift card will be mailed upon completion of the data collection 
process during the three days following surgery. 
 
XI.  THIS STUDY IS AFFILIATED WITH ANOTHER IRB-APPROVED STUDY 
 
We are collaborating research efforts with IRB Protocol 2008-0514 in order to 
determine if type of anesthesia (specifically type of sciatic nerve block) may have 
any effect on outcomes after ACL-Reconstruction. Therefore subjects that have 

 
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previously been enrolled in study 2008-0514, and have also been enrolled in this 
current project will be shared amongst the study staff to merge the data and 
investigate the effect of type of sciatic nerve block on outcomes after ACLR. For 
this retrospective analysis, we are requesting a waiver of documentation. 
Prospectively, subjects that are enrolled in the sciatic nerve block study will also 
be recruited for the ACL Outcomes study and those subjects that consent for 
participation in both will be shared amongst the studies. 
 

 
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XI. 
REFERENCE 
 
Agin, C. W., & Glass, P. S. (2005). Tolerance and aging: Optimizing analgesia in  
 
pain management. Anesthesia & Analgesia, 100(6), 1731-1732. 
Beales, J. G., Holt, P. J., Keen, J. H., & Mellor, V. P. (1983). Children with  
 
juvenile chronic arthritis: their beliefs about their illness and therapy.  
 
Annals of the rheumatic diseases, 42(5), 481-486. 
Bushnell, B.D., Sakryd, G., & Noonan, T.J. (2010). Hamstring donor-site block:  
 
evaluation of pain control after anterior cruciate ligament reconstruction.  
 
Arthroscopy, 26(7), 894 – 900. 
Distad, B. J., & Weiss, M. D. (2013). Clinical and electrodiagnostic features of  
 
sciatic neuropathies. Physical medicine and rehabilitation clinics of North  
 
America, 24(1), 107-120. 
Field, A. (2009). Discovering statistics using SPSS. Sage publications. 
Frost, S., Grossfeld, S., Kirkley, A., Litchfield, B., Fowler, P., & Amendola, A.  
 
(2000). The efficacy of femoral nerve block in pain reduction for outpatient  
 
hamstring anterior cruciate ligament reconstruction: a double-blind,  
 
prospective, randomized trial. Arthroscopy, 16(3), 243 – 248. 
Gagnier, J.J., Morgenstern, H., & Chess, L. (2012). Interventions designed to 
prevent anterior cruciate ligament injuries in adolescents and adults: A 
systematic review and meta-analysis. American Journal of Sports 
Medicine, Advance online publication. doi: 10.1177/0363546512458227. 
Gravetter, F.J. & Wallnau, L.B. (2000). Statistics for the behavioral sciences.  
 
WadsworthThompson Learning: Australia. 
Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., & Conde, J. G. 
(2009). Research electronic data capture (REDCap)—a metadata-driven  
methodology and workflow process for providing translational research 
informatics support. Journal of biomedical informatics, 42(2), 377-381. 
Kimberlin, C. L., & Winterstein, A. G. (2008). Validity and reliability of  
 
measurement instruments used in research. Am J Health Syst Pharm,  
 
65(23), 2276-84.  
Mathews, L. (2011). Pain in children: neglected, unaddressed and mismanaged.  
 
Indian journal of palliative care, 17(Suppl), S70. 
Mehta, V.M., Mandala, C., Foster, D., & Petsche, T.S. (2010). Comparison of  
 
revision rates in bone-patella tendon-bone autograft and allograft anterior  
 
cruciate ligament reconstruction. Orthopedics, 33(1), 12. 
Pallis, M., Svoboda, S.J., Cameron, K.L., & Owens, B.D. (2012). Survival  
 
comparison of allograft and autograft anterior cruciate ligament  
 
reconstruction at the United States military academy. American Journal of  
 
Sports Medicine, 40(6), 1242 – 1246.  
Polit, D.F. & Beck, C.T. (2004).  Nursing research:  Principles and methods (7th 
Ed.). Philadelphia, PA:  Lippincott Williams & Wilkins. 
Pinczewski, L.A., Lyman, J., Slamon, L.J., Russell, V.J., Roe, J., & Linklater, J.  
 
(2007). A 10-year comparison of anterior cruciate ligament reconstructions 
with hamstring tendon and patellar tendon autograft: A controlled,  
prospective trial. American Journal of Sports Medicine, 35(4), 564-574. 

 
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Shaw, T., Williams, M.T., & Chipase, L.S. (2005). Do early quadriceps exercises  
 
affect the outcome of ACL reconstruction? A randomized controlled trial.  
 
Australian Journal of Physiotherapy, 51(1), 9-17. 
Silvers, H.J., & Mandelbaum, B.R. (2007). Prevention of anterior cruciate  
 
ligament injury in the female athlete. British Journal of Sports Medicine,  
 
41(Suppl 1), 52-59. 
Tran, K.M., Ganley, T.J., Wells, L., Ganesh, A., Minger, K.I., & Cucchiaro, G.  
 
(2005). Intraarticular bupivacaine-clonidine-morphine versus femoral- 
 
sciatic nerve block in pediatric patients undergoing anterior cruciate  
 
ligament reconstruction. Anesthesia & Analgesia, 101(5), 1304 - 1310.   
Twycross, A. (2002). Educating nurses about pain management: the way  
 
forward. Journal of Clinical Nursing, 11(6), 705-714. 
Warner, R.M. (2013). Applied statistics: From bivariate through multivariate  
 
techniques. Sage Publishing: Los Angeles. 
Wegener, J.T., van Ooij, B., van Dijk, N., Hollmann, M.W., Preckel, B., & Steven,  
 
M.F. (2011). Value of single-injection or continuous sciatic nerve block in  
 
addition to a continuous femoral nerve block in patients undergoing total  
 
knee arthroplasty: A prospective, randomized, controlled trial. Regional  
 
Anesthesia and Pain Medicine, 36(5), 481-488. 
 
 
 
 

 
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Appendix A 
Preoperative Data Collection Instrument 
 
 
PATIENT STUDY ID NUMBER: ____________________________________________ 
 
 
Age (in years) on day of recruitment: ______________________________________ 
 
 
Gender (circle one):     
 
Male 
 
Female 
 
 
BMI: 
 
 
ASA physical status (circle one): 
 
I 
 
II 
 
 
Previous surgery: 
 
 
 
Yes 
 
No 
 
 
 
If yes, what surgery? ______________________________________________ 
 
 
Self-reported preoperative pain score (0 = no pain, 10 = worst pain): ______________ 
 
 
Self-reported tolerance of pain (circle one): 
 
0 = Low tolerance of pain  
1 = Moderate tolerance of pain 
2 = High tolerance of pain 
 
Self-reported level of activity since the time of ACL injury (circle one):  
 
0 = Not active at all 
1 = Not active 
2 = Partially active 
3 = Active 
4 = Highly active 
What is your level of anxiety today (0 = no anxiety, 10 = worst anxiety): _____________ 
- 
Are you normally anxious (yes/no)? ________________________________ 
- 
Do you take any prescriptive medications for anxiety (yes/no)? ___________ 
- 
Are you currently, or have you in the past, seen a healthcare professional for  
treatment of your anxiety (yes/no)? ____________________________________ 

 
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Orthopedic surgeon (circle one): 
 
Wall 
 
Parikh  
Appendix B 
Post-Discharge Data Collection Instrument 
 
PAIN CONTROL: 
 
Keep track of your pain score and location of pain:  
 
Pain score: 0 = no pain, 10 = worst pain 
Pain location: F = front of knee, B = back of knee, X = both front & back 
6 hours
42 hours
12 hours
48 hours
18 hours
 
54 hours
 
24 hours
60 hours
30 hours
 
66 hours
 
36 hours
72 hours
 
Date and time the leg was no longer numb behind the knee: _____________ 
 
 
 
Pain medicine prescribed (circle one):       Vicodin       Percocet       Other: ___________ 
 
 
Write down every time pain medication is taken: 
 
Time/date
Type of medicine
Number of pills
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ACTIVE KNEE MOVEMENT: 
 
Rate the ability to bend the knee that was operated on: 
 
 
Knee Movement 
12 
hours
24 
hours
36 
hours
48 
hours
60 
hours
72 
hours
0 = Able to bend with no pain  
 
1 = Able to bend, but with pain  
 
2 = Too much pain to bend 
 
 
 
 
 
 
 
 
 
SATISFACTION: 
 
Rate your overall satisfaction score with pain management: 
 
Satisfaction Score 
12 
hours
24 
hours
36 
hours
48 
hours
60 
hours
72 
hours
0 = Not satisfied at all 
 
1 = Not satisfied 
 
2 = Partially satisfied 
 
3 = Satisfied 
 
4 = Highly satisfied
 
 
 
 
 
 
 
 
From your perspective, have you encountered any unexpected postoperative 
experiences? 
______________________________________________________________________
______________________________________________________________________
______________________________________________________________________