Conditions: Acute Pain
Keywords: Hip Anesthesia,conduction arthroplasty
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
There is Controversy about what is more critical volume or concentration to achieve an optimum analgesic treatment with quadratus lumborum block. From the experiences of the authors, the regular dose of 20 ml of Bupivacaine at 0.375% concentration could not be enough in some cases to produce an optimum analgesic treatment, especially in hip arthroplasties. What is proposed in this study is to evaluate whether the volume injected in the quadratus lumborum block is more important than the concentration of the local anesthetic in terms of control of pain during the next 24 hours after surgery and opioid consumption.

Detailed description:
The Quadratus Lumborum Block (QLB) was originally described by Blanco in 2007 as a posterior variation of the Transversus Abdominis Plane block. It is now, however, recognized as a unique, alternative, and separate interfascial plane block. The QLB has been studied and compared with other types of blocks and it may offer several advantages such as simplicity, safety, and avoidance of hypotension. Additionally, dermatomal coverage may be greater than for other types of blocks. In cadaveric studies the paravertebral spread of dye was found from T7-L5 , although an vivo study in healthy volunteers showed the paravertebral spread of the contrast solution only between T10-L1 at 1 hour after the block. It is noted that while these anatomical studies invariably show the spread of contrast or dye extending to the paravertebral space that spread may be limited in degree. Thus follows a point of significant controversy as to whether the paravertebral space is in fact the block's primary site of action or whether it acts primarily on nerves, radicular and sympathetic, situated in the thoracolumbar fascia. Questions of mechanism and site of action notwithstanding, the safety and clinical efficacy of this block has been clearly demonstrated in multiple types of surgeries including abdominal laparoscopic , open laparotomy , urologic , and general surgery with analgesia lasting roughly 24 hours, decreased consumption of opioids, decreased time to ambulation, and decreased hospital length of stay. In recent studies, QL block employment was shown to produce a significant reduction in length of stay during hip surgery as well as similar analgesia to Lumbar Plexus blockade.

The quadratus lumborum block has since 2016 become standard of care for abdominal and hip surgeries at our institution, replacing paravertebral and lumbar plexus blocks respectively, and as part of a broader multimodal analgesia institutional ERAS (Enhanced Recovery After Surgery) protocol. Coincident with its implementation we have seen significant reductions in opiate and PCA use as well as hospital length of stay. Similar results have been reported by other institutions.

Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. There remain many unanswered questions regarding this block and its subtypes. It is, for example, unknown if one technique would be better than another for different types of surgery. Likewise little is known of the relative importance of local anesthetic concentration and injectate volume - the principal question addressed by this proposed study.

Arms:
arm 1: 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each subject received 20mL Bupivacaine 0.375%. arm 2: 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each subject was given 20mL Bupivacaine 0.375% diluted with 20mL normal saline to total 40mL (concentration decreased by half - 0.1875%).

Interventions: intervention 1: Drug: Bupivacaine 0.375% 20 mL intervention 2: Drug: Bupivacaine 0.375% diluted to 0.1875%
Intervention descriptions: intervention 1: 20 mL 0.375% Bupivacaine intervention 2: Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL)

Protocol document:
Prot_SAP_003.pdf: 
STUDY TITLE: Volume versus concentration: A prospective, double blind, parallel study 
to compare the clinical effectiveness of single shot quadratus lumborum block using 
either a high volume / low concentration or low volume / high concentration injectate for 
total hip arthroplasty  
 
PRINCIPAL INVESTIGATOR: Anna Uskova, MD 
* Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh 
Medical Center, Pittsburgh, PA 
 
NCT #: 04259645 
 
IRB ID: STUDY19090192 
 
STUDY PROTOCOL 
 
DOCUMENT APPROVAL DATE: 01/16/2020 
 
 


Our sample size in based on a previous study by Yousef NK. Where the total dose of 
morphine/patient was used to calculate sample size. The sample size was found to be 
28 patients in each group assuming a standard deviation of 3.9 mg of morphine as 
rescue analgesic (from the pilot study), α error of 0.05, β error of 0.2, and a power of 
80%. We intended to include 30 patients in each group to compensate for excluded 
patients 
 
1.Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block 
in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective 
Controlled Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. doi: 
10.4103/aer.AER_108_18. PubMed PMID: 30283187; PubMed Central PMCID: 
PMC6157234. 


Protocol title: Volume versus concentration: A prospective, double blind, 
parallel study to compare the clinical effectiveness of single shot quadratus 
lumborum block using either a high volume/low concentration or low 
volumen/high concentration injectate for total hip arthroplasty 
 
P.I: Anna Uskova M.D 
 
Co-Investigators:   Bruce Ben-David M.D 
                               Manuel Torres Grajales M.D 
                               Javier J. Polania M.D 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
Background 
 
The Quadratus Lumborum Block (QLB) was originally described by Blanco in 2007 (1) as 
a posterior variation of the Tranversus Abdominis Plane block. It is now, however,  
recognized as a unique,  alternative, and separate interfascial plane block. The QLB has 
been studied and compared with other types of blocks and it may offer several advantages 
such as simplicity, safety, and avoidance of hypotension. Additionally, dermatomal 
coverage may be greater than for other types of blocks.(2) In cadaveric studies the 
paravertebral spread of  dye was found from T7-L5 (3), although an vivo study in healthy 
volunteers showed the paravertebral spread of the contrast solution only between T10-L1 at 
1 hour after the block. (4) It is noted that while these anatomical studies invariably show 
the spread of contrast or dye extending to the paravertebral space that spread may be 
limited in degree. Thus follows a point of significant controversy as to whether the 
paravertebral space is in fact the block’s primary site of action or whether it acts primarily 
on nerves, radicular and sympathetic, situated in the thoracolumbar fascia. Questions of 
mechanism and site of action notwithstanding, the safety and clinical efficacy of this block 
has been clearly demonstrated in multiple types of surgeries including abdominal 
laparoscopic (5), open laparotomy (6), urologic (7,8), and general surgery (9) with 
analgesia lasting roughly 24 hours, decreased consumption of opioids, decreased time to 
ambulation, and decreased hospital length of stay. In recent studies, QL block employment 
was shown to produce a significant reduction in length of stay during hip surgery as well as 
similar analgesia to Lumbar Plexus blockade. 
 
The quadratus lumborum block has since 2016 become standard of care for abdominal and 
hip surgeries at our institution, replacing paravertebral and lumbar plexus blocks 
respectively, and as part of a broader multimodal analgesia institutional ERAS (Enhanced 
Recovery After Surgery) protocol. Coincident with its implementation we have seen 
significant reductions in opiate and PCA use as well as hospital length of stay. Similar 
results have been reported by other institutions.(10)  
 
Since the first description of this technique, several approaches to and anatomic targets 
within the quadratus lumborum plane have been described although their mechanism of 
action, spread, and relative clinical effectiveness remain areas of some debate. There 
remain many unanswered questions regarding this block and its subtypes. It is, for example, 
unknown if one technique would be better than another for different types of surgery. 
Likewise little is known of the relative importance of local anesthetic concentration and 
injectate volume - the principal question addressed by this proposed study.  
 


 
 
 
 


Specific Aims 
 
1. This study will prospectively investigate the efficacy of two different volumes of 
preoperative single shot local anesthetic solution injected using the QLB lateral 
approach (Quadratus Lumborum Block type I; QLB I) in patients undergoing total 
hip arthroplasty. The primary outcome will be consumption of opioids during the 
first 24 hours after surgery. 
 
2. Secondary outcomes will include: 
 Pain measurement through VAS (Visual Analogue Score) at rest and with 
movement at 3, 6, 12, and 24 hours after surgery hours after surgery  
 Consumption of non narcotic medication during the first 24 hours after 
surgery. 
 Time to ambulation after surgery (ability to walk 100 feet). 
 Hospital length of stay. 
 Time to consumption of the first opioid after surgery. 
 Patient satisfaction 24 hours after surgery. 
 Presence of any adverse effect related with analgesic technique 
 
 
 
Hypothesis 
 
There will be a significant difference between the higher and lower volumes on opioid 
consumption during the first 24 hours after surgery. 
 
 
 
Study Design 
 
The study will be conducted as a prospective, randomized, double blinded, parallel trial at 
the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital. Institutional 
Review Board approval will be obteined before elegible patients are recruited and 
consented. Trial will be registered at www.Clinicaltrials.gov before beginning recruitment. 
 
 
 
Recruitment  
 
Potential subjects will be recruited in the preoperative area of Shadyside hospital on the day 
of their scheduled nephrectomy. Patients who agree to participate in the trial will be asked 
to sign an IRB approved informed consent form. 60 patients are expected be enrolled in this 
trial with 30 in each group. 
 
 
 
 


Randomization process 
 
Participating patients will be randomized by computer generated random allocation to have 
both of the  QLBs performed with either Low Volume [ropivacaine 0.75% x 20 mL] or 
High Volume [ropivacaine 0.375% x 40 mL] injectate. All blocks will have the standard 
additives of dexmedetomidine  0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 
mcg for age >70) + dexamethasone 4 mg. 
 
 
Inclusión criteria 
 Patients 18-90 years old 
 Patients undergoing total hip arthroplasty 
 BMI 19-45, >40 kg 
 Male and Female 
 All races 
 ASA I, II, III 
 Spinal Anesthesia Provided 
 
Exclusion Criteria 
 Patient refusal 
 Pregnancy 
 Non english speaking or inability to participate in the study 
 Patients with coagulopaty or With INR >1,5 the day of the surgery. 
 Chronic steroid use 
 Chronic pain 
 Chronic opiate use  
 
Treatment Groups: 
 
Both groups will receive QLBI as described below:  
 
With the patient in the lateral position and following sterile prep and draping,  a low 
frequency curvilinear ultransound probe with sterile cover is positioned transversely 
between the iliac crest and the costal margin at the level of the anterior axillary line. The 
three muscle layers of the lateral abdominal wall (external and internal obliques, 
transversus abdominis) are identified and traced postero-laterally until the transversus 
abdominis tapers off into its hyperechoic aponeurosis. At this point the QL muscle is 
identified deep and lateral to the aponeurosis. The probe is advanced further postero-
laterally to position the quadratus muscle mid-screen on the ultrasound. A 22-g Tuohy 
needle is inserted in plane from anteromedial to posterolateral to position the needle tip at 
the interfascial plane  deep to the thoracolumbar fascia and superficial to the Quadratus 
Lumborum muscle. The optimal point of injection is determined using hydrodissection 
(QLB 1).(6) 
 
Group Low Volume: 30 subjects randomized to Low Volume will receive QLBI. Each 
block of 0,75% ropivacaine x 20 mL +  dexmedetomidine  0.4 mcg/kg (max dose 30 mcg 
for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg 


 
Group High Volume:  30 subjects randomized to High Volume will receive QLBI. Each 
block of 0,375% ropivacaine x 40 mL  +  dexmedetomidine  0.4 mcg/kg (max dose 30 mcg 
for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg 
 
 
Anesthetic management 
 
Participants in both treatment groups will receive standard ERAS multi-modal analgesic 
pre-operatively (celebrex 200 mg PO and acetaminophen 1000 mg PO) and will receive the 
estándar ERAS anesthestic technique intraoperatively (spinal neuroaxial block with 
hyperbaric bupivacaine in estándar doses 1.4-1.6 ml), introperative propofol infusion(50-
100 mcg/kg/min) intravenous dexmedetomidine (12-20 mcg) infusion, and intravenous 
ketamine (20mg). 
Patients will receive antiemetic prophylaxis with haloperidol 0.5 – 1.0 mg IV 
intraoperatively and rescue ondansetron 4 mg IV in PACU. All patients will receive 
standard ERAS fluid management intraoperatively. Postoperative pain management will 
also follow standard ERAS protocol to include acetaminophen 1000 mg PO q6h, 
gabapentin 300 – 600 mg PO qhs, PO ketamine 10-30 mg q8hrs, celecoxib 200 mg PO 
BID. Rescue analgesic medication will include Oxycodone 5 – 10 mg q4hr PRN, and 
hydromorphone 0,2 – 0.4 mg IV q1hr for severe pain (VAS>5). 
 
 
Data collection and Outcome Measures 
 
Once the patient has signed the informed consent document they will be randomly assigned 
to one of the two study groups as described. Only the persons administering the block will 
be unblinded to the patient’s group assignment.  Both the patient and the outcome assesors 
will be blinded to that assignment.  
 
 Primary outcome: VAS pain score at 3, 6, 12, and 24 hours after surgery will documented 
by one of the Investigator.  Patients will also asked to respond on a scale (Liker Type) from 
1-5 how would he/she describe the pain management during the first 24 hours after surgery. 
Other variables such as total opioid consumption, length of hospital stay, consumption of 
non narcotic analgesics,and time to consumption of the first opioid after surgery will be 
abstracted from the electronic medical record. 
 
 
Statistical analysis plan 
 
Continuous patient/procedure variables (age, weight, height, body mass index, duration of 
surgery, length of stay, morphine equivalent opiate analgesic requirement, visual analog 
pain scales, time to the first opioid requeriment after surgery) will be analyzed using t test 
(normally distributed data) or Rank sum test (for not normally distributed data). 
Dichotomous variables (gender, incidence of complications eg. postoperative nausea and 
vomiting, and analgesia related complications) will be analyzed by Chi square and Fischer 
exact test. SPSS and Stata programs will be used for statistical analysis. 


 
 
 
 
 
REFERENCES 
 
 
1.  
Blanco R. Tap block under ultrasound guidance: the description of a “no pops” 
technique. Reg Anesth Pain Med. 2007;32(Suppl. 1):130.  
 
2.  
Tamura T, Kitamura K, Yokota S, Ito S, Shibata Y, Nishiwaki K. Spread of 
Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: 
A Volunteer Study. Reg Anesth Pain Med. 2018;43(4):372–7. 
  
3.  
Elsharkawy H, Bajracharya GR, El-Boghdadly K, Drake RL, Mariano ER. 
Comparing two posterior quadratus lumborum block approaches with low thoracic 
erector spinae plane block: An anatomic study. Reg Anesth Pain Med. 
2019;44(5):549–55.  
 
4.  
Tamura T, Yokota S, Ito S, Shibata Y, Nishiwaki K. Local anesthetic spread into the 
paravertebral space with two types of quadratus lumborum blocks: a crossover 
volunteer study. J Anesth [Internet]. 2019;33(1):26–32. Available from: 
http://dx.doi.org/10.1007/s00540-018-2578-5 
 
5.  
Murouchi T, Iwasaki S, Yamakage M. Quadratus lumborum block: Analgesic effects 
and chronological ropivacaine concentrations after laparoscopic surgery. Reg Anesth 
Pain Med. 2016;41(2):146–50.  
 
6.  
Blanco R, Børglum J. Analgesia in Major Abdominal Surgery. Analg Major Abdom 
Surg. 2018;  
 
7.  
Lee AJ, Yabes JG, Hale N, Hrebinko RL, Gingrich JR, Maranchie JK, et al. The 
comparative effectiveness of quadratus lumborum blocks and paravertebral blocks in 
radical cystectomy patients. Can J Urol 2018;25(April):9255–61.  
 
8.  
Graça R, Miguelez P, Cardoso JM, Sá M, Brandão J, Pinheiro C, et al. Continuous 
quadratus lumborum type II block in partial nephrectomy. Brazilian J Anesthesiol. 
2018;68(6):653–6.  
 
9.  
Ökmen K, Metin Ökmen B, Topal S. Ultrasound-guided posterior quadratus 
lumborum block for postoperative pain after laparoscopic cholecystectomy: A 
randomized controlled double blind study. J Clin Anesth [Internet]. 
2018;49(January):112–7. https://doi.org/10.1016/j.jclinane.2018.06.027 
 
10.  
Akerman M, Pejčić N, Veličković I. A Review of the Quadratus Lumborum Block 
and ERAS. Front Med. 2018;5(February):1–7.  


 
 
 
 
 

ICF_004.pdf: 
STUDY TITLE: Volume versus concentration: A prospective, double blind, parallel study 
to compare the clinical effectiveness of single shot quadratus lumborum block using 
either a high volume / low concentration or low volume / high concentration injectate for 
total hip arthroplasty 
 
PRINCIPAL INVESTIGATOR: Anna Uskova, MD 
* Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh 
Medical Center, Pittsburgh, PA 
 
NCT #: 04259645 
 
IRB ID: STUDY19090192 
 
INFORMED CONSENT FORM 
DOCUMENT APPROVAL DATE: 01/16/2020 


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Department of Anesthesiology 
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY 
TITLE: Volume versus concentration: A prospective, double blind, parallel study to compare 
the clinical effectiveness of single shot quadratus lumborum block using either a high 
volume/low concentration or low volumen/high concentration injectate for total hip arthroplasty 
 
PRINCIPAL INVESTIGATOR: 
Anna Uskova, MD 
UPMC Shadyside 
5230 Centre Avenue 
Pittsburgh, Pennsylvania 15232 
412.623.6904 
 
CO-INVESTIGATORS: 
Bruce Ben-David, MD 
Jacques Chelly MD 
Manuel Torres Grajales MD 
Sharad Khetarpal MD 
Goel Shiv MD 
Carl Rest MD 
Javier J. Polania MD 
 
SOURCE OF SUPPORT: 
None 
NOTE: A copy of this consent will be archived in the chart of the patient. 
Why is this research being done? 
Pain management after hip joint surgery is essential: not only does it guarantee your comfort but 
also allows you to walk earlier after surgery. One of the procedures that is standard of care for 
pain management for this surgery is called the “quadratus lumborum block.” The quadratus 
lumborum block is actually placed by using a needle attached to a syringe of numbing medicine 
inserted into your back (called ‘injection") that is guided by ultrasound imaging. The numbing 
medicine works to blocks your nerves so you don't feel pain, or any sensations during the surgery 
in that area. The anesthesiologist who will place the injection will also use ultrasound to guide 
where the needle is placed. Ultrasound is when a wand device is used to apply sound waves 
through a gel to produce an image of the area. You may have heard the term "sonogram" which 
is the image the ultrasound produces. The ultrasound allows us to have an inside view of soft 
tissues (muscles, fat, tendons) in your back as we do the injections. It is essential for you to know 
that these injections are not going to be located in your spine. The injections will be located at 
your right and left back muscles and will help you to reduce your pain after surgery. 


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This type of block or injection is standard of care for hip joint surgery. However, there is no 
agreement yet about what is the best concentration and volume (quantity of liquid to inject) for 
these injections. Concentration means how much medicine is dissolved in the volume of liquid 
that is injected. If the volume is changed, it changes the concentration. And we would like to 
know if the difference between concentrations and volume affects pain control after surgery. The 
purpose of this study is to evaluate two different sets of concentrations and volumes (quantity of 
liquid to inject), with the same amount of numbing medicine that has been shown to produce 
pain relief after surgery. 
 
Who is being asked to take part in this research study? 
You are being invited to participate in this research study because you will undergo hip joint 
surgery. People being invited to participate must be over 18 years of age. We will enroll 60 
subjects. 
 
What procedures will be performed for research purposes? 
 
Screening Procedures: 
 
There are no specific screening tests or procedures for this research study. 
Research Procedures: 
If you qualify to take part in this research study, you will undergo the procedures listed below: 
 
You will be randomized, or assigned by chance, via a computer-generated number system, into 
one of the two intervention groups. Randomized is like flipping a coin where you have a 50:50 
chance of being assigned to either group. One group will have their pain relief medication in a 
solution of about 4 teaspoons of liquid and the other group will have theirs in a volume of 8 
teaspoons. The concentration of the medication will be lower in the group that has the 8 tsp. 
volume. Sterile salt water is used to dilute the medication and is safe for this use. 
 
After the randomization, you will receive the hospital’s standard of care intervention for pain 
control. This consists of a multi-modal pain management regimen, meaning using different types 
of drugs to control your pain, including a nerve block, the Quadratus Lumborum Block. 
 
For this study, the only differences will be the concentration and volume of liquid that is injected 
during the nerve block. You will receive the same amount of numbing medicine as if you were 
not included in the study, but this amount of numbing medicine could be more or less diluted. 
This study is double-blind, so neither you nor your surgeon or nurses will know which volume 
you receive. The only person aware of what volume you receive will be the anesthesiologist 
performing the injection. 
 
Monitoring/Follow-up Procedures 
Your participation in the study will be for 24 hours after your surgery. We will follow up with 
you to do the following tests: 
 
• Pain Level: We will ask you to rate your pain with movement and at rest on a scale of 1- 
10. We will ask you at 3, 6, 12 and 24 hours after surgery. 


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• We will collect this information from your medical record: 
 
o Pain Medications Consumption: We will record when your 1st request for pain 
medication occurs; also, we will you’re the total pain medications (narcotics and 
non-narcotic analgesics) given to you in 24 hours or until discharge. 
 
o Mobility: we will record from the physical therapist note when you are were able 
to walk 100 feet. 
 
• Pain Management Survey: At 24 hours after surgery, the investigator will ask you a few 
questions regarding your satisfaction with your pain management. 
What are the possible risks, side effects, and discomforts of this research study? 
There are risks associated with your surgery, anesthesia, and hospitalization. These risks will be 
discussed with you by your surgeon and anesthesiologist and are independent of your participation in this 
research study. 
 
Risks associated with participation in the study are: 
1. Changing the concentration and volume of liquid in the Quadratus Lumborum block may 
result in less or more effective pain management. It may require you take more of other 
pain medications. 
 
Your medical record will be accessed by study team. Some of the information reviewed 
and recorded from your medical record includes medical history, surgical and anesthesia 
record, medication record and pain scores. All of your medical record and study-related 
information will be considered protected health information and will be kept confidential 
per HIPAA privacy act. There is, however, a risk of breach of confidentiality. That is, in 
very rare cases, people not associated with this research study may inadvertently see your 
identifiable research results. We will do everything in our power to prevent this from 
happening by keeping all research records in locked files and identify medical 
information by a research record number, rather than by your name or social security 
number. The codebook containing your name and number will be kept secure by the 
study team. 
What are possible benefits from taking part in this study? 
There is a potential benefit to you if one of the groups is shown to have better pain relief and/or 
requires less opioids. 
What treatments or procedures are available if I decide not to take part in this research study? 
If you decide not to take part in this research study, you will receive the standard of care anesthesia 
and post-operative pain management. 
If I agree to take part in this research study, will I be told of any new risks that may be found 
during the course of the study? 
You will be promptly notified if, during the conduct of this research study, any new information 
develops which may cause you to change your mind about continuing to participate. 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 


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by US Law. This website will not include information that can identify you. At most, the website 
will include a summary of the results. You can search this website at any time. 
Will my insurance provider or I be charged for the costs of any procedures performed as part 
of this research study? 
Some of the services you will receive during this study are considered to be “routine clinical 
services” that you would have even if you were not in the study. These services will be billed to 
your health insurance company or you, if you do not have health insurance. 
You will be responsible for paying any deductibles, co-payments or co-insurance that are a 
normal part of your health insurance plan. 
 
You may talk to a member of the study staff and/or a University of Pittsburgh Medical Center 
(UPMC) financial counselor to get more information on your routine clinical services costs. 
These costs are not connected to any study activity. 
 
Alternative treatments 
If you do not participate in this study, you will likely still participate in the ERAS protocol as it 
is the standard of post-operative care at UPMC facilities and will receive nerve block according 
to anesthesiologist’s preference. 
 
Will I be paid if I take part in this research study? 
You will not receive any payment for participating in this research study. 
 
Who will pay if I am injured as a result of taking part in this study? 
University of Pittsburgh researchers and their associates who provide services at UPMC 
recognize the importance of your voluntary participation in their research studies. These 
individuals and their staffs will make reasonable efforts to minimize, control, and treat any 
injuries that may arise as a result of this research. If you believe that you are injured as a result 
of the research procedures being performed, please contact immediately the Principal 
Investigator listed on the first page of this form. Emergency medical treatment for injuries solely 
and directly related to your participation in this research study will be provided to you by the 
hospitals of UPMC. It is possible that UPMC may bill your insurance provider for the costs of 
this emergency treatment, but none of these costs will be charged directly to you. If your 
research-related injury requires medical care beyond this emergency treatment, you will be 
responsible for the costs of this follow-up care unless otherwise specifically stated below. There 
is no plan for monetary compensation. You do not, however, waive any legal rights by signing 
this form. 
 
Who will know about my participation in this research study? 
Any information about you obtained from this research will be kept as confidential (private) as 
possible. All records related to your involvement in this research study will be stored in a locked 
file cabinet, which will include information collected from your electronic medical record. Your 
identity on these records will be indicated by your name, medical record number, specific study 
case number. The purpose of these identifiers is strictly for study procedures in order to confirm 
your eligibility for the study, as well as follow up procedures. Only authorized research staff will 
have access to these research records. All confidential subject folders will be kept in a locked file 
cabinet for 7 years after the conclusion of the study and will then be sent to records management. 
You will not be identified by name in any publication of the research results. We will attempt to 


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preserve your medical record and participation in this study as confidentially as possible, but 
breach of confidentiality is a risk of participation. 
 
In the future, the investigators may decide to share data with other investigators both within and 
outside of this institution. If that were to occur, we would de-identify all of the information prior 
to sharing any data in this way. 
 
Will this research study involve the use or disclosure of my identifiable medical information? 
This research study will involve the recording of past, current and/or future identifiable 
(pertaining to only you) medical information from your hospital and/or other health care provider 
(e.g. physician office) records. This information that will be recorded will be limited to 
diagnostic information, lab results, medications, and medical history. The information will be 
used to determine your eligibility for this study and to follow your care once you are enrolled in 
the study. 
 
If you participate in this study, identifiable information will be placed into your medical records held at 
UPMC, including a copy of this consent form. The nature of the identifiable information resulting 
from your participation in this research study that will be recorded in your medical record 
includes: 
-which volume is administered and that you are a participant in this study 
-response to study treatment including adverse events (side effects). 
 
 
Who will have access to identifiable information related to my participation in this 
research study? 
In addition to the investigators listed on the first page of this authorization (consent) form and 
their research staff, the following individuals will or may have access to identifiable information 
(which may include your identifiable medical information) related to your participation in this 
research study: 
 
Authorized representatives of the University of Pittsburgh Office of Research Protections 
may review your identifiable research information (which may include your identifiable 
medical information) for the purpose of monitoring the appropriate conduct of this 
research study. 
 
Authorized representatives of the study team, who are also part of the Department of 
Anesthesiology and the Acute Interventional Perioperative Pain Service, will review 
and/or obtain identifiable information (which may include your identifiable medical 
information) related to your participation in this research study for the purpose of 
monitoring the accuracy and completeness of the research data and for performing 
required scientific analyses of the research data. 
 
Authorized representatives of the UPMC hospitals or other affiliated health care 
providers may have access to identifiable information (which may include your 
identifiable medical information) related to your participation in this research study for 
the purpose of (1) fulfilling orders, made by the investigators, for hospital and health care 
services (e.g., laboratory tests, diagnostic procedures) associated with research study 
participation; (2) addressing correct payment for tests and procedures ordered by the 


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investigators; and/or (3) for internal hospital operations (i.e. quality assurance). 
 
In unusual cases, the investigators may be required to release identifiable information 
(which may include your identifiable medical information, this include but not limited to: 
your name, diagnoses, treatments, age, sex, weight) related to your participation in this 
research study in response to an order from a court of law. If the investigators learn that 
you or someone with whom you are involved is in serious danger or potential harm, they 
will need to inform, as required by Pennsylvania law, the appropriate agencies. 
 
For how long will the investigators be permitted to use and disclose identifiable information 
related to my participation in this research study? 
The investigators may continue to use and disclose, for the purposes described above, identifiable 
information (which may include your identifiable medical information) related to your 
participation in this research study for an indefinite period of time. 
 
May I have access to my medical information that results from my participation in this 
research study? 
In accordance with the UPMC Notices of Privacy Practices document that you have been 
provided, you are permitted access to information (including information resulting from your 
participation in this research study) contained within your medical records filed with your health 
care provider. 
 
Is my participation in this research study voluntary? 
Your participation in this research study is completely voluntary. Whether or not you provide 
your consent for participation in this research study will have no effect on your current or future 
relationship with the University of Pittsburgh. Whether or not you provide your consent for 
participation in this research study will have no effect on your current or future medical care at a 
UPMC hospital or affiliated health care provider or your current or future relationship with a 
health care insurance provider. 
 
Your anesthesiologist is involved as an investigator in this research study. As both your doctor 
and a research investigator, s/he is interested both in your medical care and the conduct of this 
research study. Before agreeing to participate in this research study, or at any time during your 
study participation, you may discuss your care with another doctor who is not associated with 
this research study. You are not under any obligation to participate in any research study offered 
by your anesthesiologist. 
 
May I withdraw, at a future date, my consent for participation in this research study? 
You may withdraw, at any time, your consent for participation in this research study. Any 
identifiable research or medical information recorded for, or resulting from, your participation in 
this research study prior to the date that you formally withdrew your consent may continue to be 
used and disclosed by the investigators for the purposes described above. 
 
To formally withdraw your consent for use of your medical records and/or participation in this 
research study, you should provide a written and dated notice of this decision to the principal 
investigator of this research study at the address listed on the first page of this form. 
 
Your decision to withdraw your consent for participation in this research study will have no 


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effect on your current or future relationship with the University of Pittsburgh. Your decision to 
withdraw your consent for participation in this research study will have no effect on your current 
or future medical care at a UPMC hospital or affiliated health care provider or your current or 
future relationship with a health care insurance provider. 
 
If you decide to withdraw from study participation after you have received the study drug, no 
study assessments will be done after your withdrawal. 
 
If I agree to take part in this research study, can I be removed from the study without my 
consent? 
It is possible that you may be removed from the research study by the researchers if, for example, 
you have an unexpected change, complication in your anesthesia or surgery or serious adverse 
reaction. If you are withdrawn from participation in this research study, you will still be treated for 
your post-surgical pain. Please consult your surgeon or anesthesiologist if you have any further 
concerns. 
 
 
 
 
 
****************************************************************************** 
VOLUNTARY CONSENT 
 
The above information has been explained to me and all of my current questions have been 
answered. I understand that I am encouraged to ask questions about any aspect of this research 
study during the course of this study, and that such future questions will be answered by a qualified 
individual or by the principal investigator listed on the first page of this consent document at the 
telephone number given. I understand that I may always request that my questions, concerns or 
complaints be addressed by a listed investigator. 
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, 
University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain 
information; offer input; or discuss situations in the event that the research team is unavailable. 
By signing this form, I agree to participate in this research study and to authorize Dr. Uskova and 
the members of her research team to access my medical records and extract research data from 
them, as described in this document. Dr. Uskova will sign this consent and a copy of this consent 
form will be given to me. Also, I further certify that no research component of this protocol was 
begun until after the consent form was signed. 
 
 
 
Participant’s Signature 
 
 
 
Printed Name of Participant 
Date/Time 


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CERTIFICATION of INFORMED CONSENT 
 
I certify that I have explained the nature and purpose of this research study to the above-named 
individual(s), and I have discussed the potential benefits and possible risks of study participation. 
Any questions the individual(s) have about this study have been answered, and we will always be 
available to address future questions as they arise. I further certify that no research component of 
this protocol was begun until after this consent form was signed. 
 
 
 
Printed Name of Person Obtaining Consent 
Role in Research Study 
 
 
 
Signature of Person Obtaining Consent 
Date /Time