Clinical trial NCT03115151
Conditions: Pain
Sponsor: University of Texas Southwestern Medical Center
Start date: 2017-05-08; Completion date: 2023-04-04
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.

Detailed description:
Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:

1. Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
2. Intravenous Patient-Controlled Analgesia (IV PCA)

Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.

For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.

Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.

Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding specific concerns).

Visual analog pain scale (VAS) will be used to evaluate degree of pain at 3, 24, 48, and 72 hours after surgery.

Additionally, both the IV PCA and the epidural PCEA groups may be given additional "rescue" pain medications as needed in the recovery room, and these may be continued through the post-operative period on the floor.

Total study duration is approximately 50 days, which starts from operating room admission for spinal fusion surgery to the first follow-up visit after discharge.

Arms: arm 1: Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours arm 2: Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone
Interventions: intervention 1: Bupivacaine intervention 2: Hydromorphone intervention 3: Fentanyl
Intervention descriptions: intervention 1: Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter intervention 2: Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL). intervention 3: Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
Official title:  A Comparison of Epidural and Intravenous 
Patient Control Analgesia Following Lumbar Spinal Fusion 
Surgery: A Prospective Randomized Study 
 
NCT number: NCT03115151 
IRB Approved date: 03-28-2022 


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The University of Texas Southwestern Medical Center at Dallas 
Institutional Review Board 
 
Protocol  
 
Title: A Comparison of Epidural and Intravenous Patient Control Analgesia Following 
Lumbar Spinal Fusion Surgery:  A Prospective Randomized Study 
 
Funding Source: Departments of Anesthesiology & Pain Management and Neurosurgery; 
University of Texas Southwestern, Dallas, Texas 
 
Principle Investigator:      
• Enas Kandil, MD, MSc; Assistant Professor of Anesthesiology & Pain Management 
Co- Principle Investigator:   
• Carlos Bagley, MD; Associate Professor of Neurosurgery 
 
 
1.  Introduction and Purpose – Postoperative analgesia following spine surgery is difficult to 
manage.  Current treatment modalities rely heavily on opioid analgesics with all of the inherent 
limitations and side effects.  While current best practice focuses on a ‘multimodal approach’ (i.e. 
using multiple different drugs and techniques to control pain after surgery), there is no 
consensus regarding which components of this multimodal therapy provide optimal analgesia. 
This prospective randomized study will enroll patients undergoing elective Lumbar Spinal 
Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the 
comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-
controlled analgesia (PCA), on post-operative analgesia. 
 
Hypothesis1: We hypothesize that patients undergoing Lumbar Spinal Fusion surgery with 
epidural catheter placement will have superior post-operative analgesia compared to patients 
receiving IV PCA.   
Specific Aim1: Patient received PCEA will have lower Visual Analog pain sores (VAS) at 24 hour 
postoperatively compared to those who received IV PCA.  
Primary outcome measure: Postoperative VAS score at 24 hours 
 
Hypothesis2: Epidural analgesia with intraoperative epidural catheter may decrease 
postoperative opioid consumption compared to IV PCA.   
Specific Aim2: Patients received PCEA with intraoperative epidural catheter will consume less 
opioid during the first 24-h postoperative period compared to those who received IV PCA.   
Secondary outcome measure: Postoperative opioid consumption within the first 24 hours. 
 
2.  Background & Significance – Low back pain is one of the most prevalent debilitating 
musculoskeletal conditions in the United States. (1) Therefore, lumbar spine surgery is a 
commonly performed procedure in the United States.  Many patients undergoing lumbar spine 
surgery have chronic pain syndromes pre-operatively which can present challenges in the 
treatment of post-operative pain.  The importance of adequate post-operative pain control has 
recently been emphasized with the awareness that inadequate treatment may result in a higher 
incidence of the development of chronic post-surgical pain and increase post-operative 
comorbidities. (2) Multiple drugs and protocols for the treatment of post-operative pain 


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following lumbar spine surgery have been studied, but no best method has been shown to date. 
(3)   
 
Most studies of lumbar spine surgery pain management have investigated comparisons 
between intravenous opioids, intrathecal local anesthetics and opioids, and epidural local 
anesthetics and opioids.  There have been mixed results regarding the superior approach to 
post-operative pain management and complications. (4-7) Several of these conflicting studies 
contain small sample sizes and have various other limitations. Therefore, further investigation 
is warranted to improve post-operative pain control following lumbar spine surgery.  The 
current study seeks to improve care of patients in the UT Southwestern Spine Center by 
comparing intravenous patient-controlled opioid analgesia versus continuous epidural 
analgesia.  There are several potential advantages to epidural therapy.  These include decreased 
opioid use leading to fewer side effects such as respiratory depression, nausea, ileus, and 
sedation. (8) Epidural analgesia has also been shown to provide better post-operative analgesia 
when compared to parenteral opioids in a variety of surgical procedures and with a variety of 
analgesic agents. (2)   
 
Ilangovan et al (2017) used intraoperatively placed epidural catheter for postoperative pain 
relief after spinal fusion surgery in terms of efficacy and cost. The investigators used epidural 
tramadol and concluded that epidural intraoperative placement of the epidural catheter is a 
simple way of delivering medication to the epidural space. Li at al. (2015) compared outcome 
of PCEA and IV PCA after spinal fusion surgery. According to their results PCEA showed 
significantly greater efficacy than IV PCA for pain management after spinal fusion surgery, with 
lower VAS scores, higher frequency of recovery activities, and overall higher satisfaction level. 
They also monitored adverse effects of PCEA and IV PCA, which includes nausea, vomiting, 
pruritus, drowsiness, respiratory depression, and headache.  In the IV PCA group, the incidence 
of hypopiesia and skin itching were higher with markedly lower drowsiness and headache 
when compared to the PCEA group.  In the current meta-analyses of randomized clinical trials, 
Lu et al (2015) compared the efficacy and safety of PCEA and IV PCA in postoperative analgesia 
of spinal fusion surgery. They showed that the analgesic effect on patients in the PCEA group 
was better than that in the IV PCA group on the first and second postoperative days without 
significant difference in analgesic effects on the third postoperative day after spinal fusion. In a 
randomized prospective clinical trial, efficacy of postoperative analgesia was evaluated in 
patients with adolescent idiopathic scoliosis undergoing posterior spinal fusion. PCEA 
effectively controlled postoperative pain with the fewest side effects (Klatt et al. 2013).  
 
Cassady et al (2000) compared continuous thoracic epidural analgesia and patient-controlled 
analgesia in postoperative care of adolescents with idiopathic scoliosis and observed 
significantly more rapid return of bowel sounds in PCEA group.  Turner et al (2000) evaluated 
intraoperative placement of epidural catheter under direct visualization of the surgeon on 14 
consecutive cases undergoing spinal fusion surgery and had epidural radio-opaque dye injected 
15 minutes before their postoperative chest X-ray. Seven patients had visible dye in epidural 
space, and all these cases had satisfactory analgesia. According to this small pilot study, 
correctly placed epidural catheters are capable of providing good postoperative analgesia for 
posterior spinal surgery. Cata et al (2008) retrospectively reviewed 245 medical records of 
adult patients undergoing major spine surgery who received either patient-controlled epidural 
analgesia based on local anesthetics and opioids or patient-controlled intravenous analgesia as 


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postoperative pain management. They showed a reduced amount of opioids with epidural 
analgesia, which may decrease potential side effects mainly in elderly patients. 
 
In a prospective, double-blind, randomized clinical trial, Schenk et al (2006) investigated the 
efficacy of PCEA compared with IV PCA and concluded that PCEA with ropivacaine and 
sufentanil, using intraoperatively placed epidural catheters, provides superior analgesia and 
higher patient satisfaction when compared with PCIA after spinal fusion surgery. Gottschalk et 
al (2004) evaluated 72 patients with intraoperative epidural catheter placement for 
postoperative analgesia for anterior-posterior spinal fusion surgery. They observed lower 
levels of pain at rest and during mobilization in the PCEA when compared to the IV PCA group. 
Cohen et al. (2) compared fixed continuous epidural analgesia (bupivacaine 0.0625%) via 
intraoperatively placed epidural catheters two or three levels above the cephalad operative 
level with IV PCA (morphine 1 mg/mL) after major spine surgery and found no differences in 
postoperative pain levels. The authors concluded that the diluted local anesthetic may not have 
reached the operative field in sufficient amounts. 
 
3.  Concise Summary – Study Design:  Prospective study of 58 subjects undergoing elective 
Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital 
with: 
 
1. 29 subjects receiving Continuous Lumbar Epidural Analgesia (Patient-Controlled 
Epidural Analgesia- PCEA groups) 
 
2. 29 subjects receiving  IV PCA 
 
Subjects will be randomly assigned one of the study groups either PCEA or IV PCA. 
Randomization protocol will be prepared according to level of the spinal fusion levels (1-
3).  
 
Study Interventions – The intervention to be evaluated in this study is epidural analgesia using 
an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml.  The Patient Controlled Epidural 
Analgesia (PCEA) pump will be programmed with the following settings: 
▪ Bolus dose 5ml following emergence from general anesthesia (after 
clinical neurologic exam) 
▪ Infusion 6-10 ml/hour; 2ml demand bolus every 20 minutes 
▪ Max dose set for infusion over 4 hours + 6 boluses (12ml) 
(Example - infusion 5ml/hr.; max 32ml over 4 hours) 
 
This infusion will continue into the post-operative period.  The epidural infusion will be 
continued until it is appropriate to transition the patient to a regimen of oral pain medications.  
This is typically determined by the surgical team, and the Acute Pain Service (APS).  Duration 
of epidural catheter will be 72 hours a postoperatively. The APS will discontinue the epidural 
infusion and remove the epidural catheter per standard protocol.  
 
For subjects in the IV PCA group, the intervention will include post-operative IV PCA with 
Hydromorphone (PCA syringe 25 mg/50 mL; dose range is 0.05mg - 0.4 mg which may be 
change according to patient`s body habitus, age, etc.).    
 


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Epidural catheters will be placed by the spine surgeon under direct visualization intra-
operatively prior to closing the surgical incision. Intra-operative epidural catheter placement 
by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy 
and the catheter will be pushed cephalad 5-10cm up the epidural space. For safety reasons, the 
subjects with dura damage during surgery will be excluded from the study because 
unpredictable amounts of the local anesthetic might reach the intrathecal space. 
 
Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the 
APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding 
specific concerns). Subjects are assessed for sensory function provided by the epidural 
(typically by sensation to cold or sharp), motor function, and any side effects or complications 
from the epidural. Motor block will be quantified with the Bromage scale (0 _ free movements 
of legs and feet, 1 _ just able to flex the knees with free movement of the feet, 2 _ unable to flex 
the knees but with free movement of the feet, and 3 _ unable to move legs or feet). Subjects will 
be asked about sensory deficits and graded on scale 1 to 3 (1 intact sensation, 2_ partial 
sensation, and 3_ complete sensation lost). 
 
Visual analog pain scale (VAS) will be used to evaluate degree of pain at, 24, 48, and 72 hours 
after surgery. If a subject reports inadequate pain control with an epidural and the APS deems 
the epidural to be non-functional or non-efficacious, then the catheter may be removed and the 
patient may be changed to an IV PCA at that time.   
 
Additionally, both the IV PCA and the epidural PCEA groups may be given additional “rescue” 
pain medications as needed in the recovery room, and these may be continued through the post-
operative period on the floor. Current standard of care is using multimodal analgesia including 
acetaminophen, COX-2 specific inhibitors, dexamethasone, etc. These rescue medications may 
include, but are not limited to:  pregabalin, gabapentin, methocarbamol, oxycodone, 
hydrocodone, methadone, and acetaminophen. 
 
Total study duration is approximately 50 days, which starts from operating room admission for 
spinal fusion surgery to the first follow-up visit after discharge.  Postoperative data will be 
collected during hospital stay and at the first follow-up visit.  
 
4. Study Procedures: 
 
Monitoring:   
Standard intraoperative monitoring (EKG, blood pressure, pulse oximetry, end-tidal carbon 
dioxide, and temperature) and anesthetic care will be used in both groups.   
 
Surgical and anesthetic technique: All subjects will undergo a standardized general 
anesthetic for the operative procedure (see Appendix 1).  The surgery and postoperative 
management will also be standardized.  The difference between patient cohorts will be the use 
of epidural vs. intravenous analgesia for post-operative pain management.  Both study groups 
will receive hydromorphone, which is a standard of care drug for post-operative pain.  If the 
subject has a documented allergy or intolerance to hydromorphone, then a different opioid may 
be substituted in either the IV PCA or the epidural drug solution.  The epidural study group will 
also receive Bupivacaine (local anesthetic) in combination with fentanyl.  The intervention 
being tested in the current study is the route of analgesic medication—intravenous or epidural, 


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as well as the addition of bupivacaine in the epidural analgesic group.  Note that bupivacaine 
contraindicated for intravenous use, and may have significant cardiac and neurologic sequelae 
if given intravenously.  Therefore, it will be included only in the epidural analgesia group.   
 
Epidurals that are evaluated and felt to be non-efficacious will be removed, and the subject will 
be changed to intravenous hydromorphone PCA.  These subjects will be statistically analyzed 
primarily by intent to treat method, with possible secondary analysis, to be analyzed in an 'as 
treated group'. Investigators will not be blinded to treatment allocation due to the nature of the 
intervention.  Subjects will be randomized to receive IV PCA or epidural PCEA. 
 
The following variables will be evaluated to determine differences between Epidural Analgesia 
and Standard Care: 
Preoperative Data Collection during preoperative outpatient clinic visit or preoperative 
period before the surgery  
 
• VAS score 
• Baseline delirium assessment (the Confusion Assessment Method (CAM) and the 
Mini-Cognition assessment (MiniCog)  
• Hospital anxiety depression scores (HADS) will be evaluated- baseline (preop) 
• Pain will also be evaluated with McGill short form questionnaire-baseline (preop).  
 
Postoperative data collection during hospital stay:  
• Post-operative Visual Analogue Pain (VAS) Score within 3 hours or PACU discharge, 
postoperative 24, 48, and 72 hours during infusion days (±2 hrs.) after surgery (Primary 
endpoint:  VAS Score at 24h).  
• Post-operative intravenous opioid consumption for postoperative days 1, 2, and 3 
(converted to Morphine Equivalents). 
• Total use of post-operative oral opioid consumption during hospital stay on 
postoperative day 3.  
• Total use of breakthrough medication on postoperative day 3. 
• Patient satisfaction score at the last infusion day or postoperative day 3 or at discharge 
if patient discharged before POD3.  
• Delirium during the hospital stay.  Patients will be assessed baseline (preop) and daily 
during epidural or IV infusion , and the 6-week follow-up using the Confusion 
Assessment Method (CAM) and the Mini-Cognition assessment.  
• Epidurals will be assessed for efficacy/function in the recovery room post-operatively 
by the Acute Pain Service, and then daily during infusion days (24, 48, and 72 hours)  
• Length of hospital stay. 
• Nausea, vomiting and antiemetic use for postoperative 72 hours  
• Time to first bowel movement after surgery 
• Wound infection rates during hospital stay 
• Time to first ambulation after surgery 
• Adverse effects include nausea, vomiting, pruritus, drowsiness, respiratory depression, 
and headache etc. 
 
Data collection during 6-week follow-up visit (approximately postoperative 50 days): 
• VAS Score 


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• HADS 
• Pain evaluation with McGill short form questionnaire 
• Patient satisfaction with post-operative analgesia 
• Readmission rates within 30 days of surgery 
• Wound infection rates until the first follow up visit 
 
5.   Criteria for Inclusion of Subjects:  
• Adult subjects aged 18 years or older  
• Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels 
 
6. Criteria for Exclusion: Patients will be excluded if they have: 
• Baseline cognitive deficits sufficient to make objective pain self-assessments 
unreliable in the estimation of the Study Investigators.   
• Immunocompromised subject 
• Coagulopathy 
• Severe liver and renal dysfunction 
• Preoperative neurological deficits 
• The dura damage during surgery 
• Inability to follow directions or comprehend the English language. 
• Females who are pregnant  
• Prisoners. 
• Patient refusal to provide informed consent. 
• Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) Fentanyl 
allergy if the subject assigned epidural analgesia 
• Hydromorphone allergy if the subject assigned IV PCA 
 
7. Sources of Research Material  
• Patient information including name, medical record number, Date of Birth, and contact 
information including phone number. 
• Weight, height, BMI, medical and surgical history, Medication list 
• Pain Scores 
• Post-operative intravenous and oral opioid consumption (Morphine Equivalents). 
• Patient satisfaction scores  
• Evaluation of cognitive function/delirium 
• Evaluation of Hospital Anxiety and Depression 
• Length of stay   
• Readmission rates 
• Wound infection rates 
 
8.  Recruitment Methods and Consenting Process: Study will be introduced to potential 
subjects via phone call or MyChart message and the informed consent form will be emailed to 
interested subject for review. If subject want to be part of the study electronic consent will be 
obtained via DocuSign. If subject not reachable, they will be  enrolled, and informed consent 
obtained in the preoperative clinic areas at UTSW Zale Lipshy University Hospital and the Spine 
Clinic during their preoperative surgery or anesthesiology visits.  All subjects who meet the 
inclusion criteria based upon planned surgical intervention and who do not fulfill any of the 


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exclusion criteria will be approached regarding the study protocol.  Therefore, all demographic 
groups in the surgical practice will be represented.   
 
Consent Process– If subject wants to be part of the study, electronic consent will be obtained 
via DocuSign. If subject is not reachable, informed consent will be obtained during the surgical 
or anesthetic pre-operative visit by the research team once a subject is identified as being 
scheduled for the included spine surgery and not fulfilling any of the listed exclusion criteria. 
 
Subject’s Capacity to Give Legally Effective Consent – Subjects who do not have the capacity 
to given legally effective consent will not be included in the study. 
 
Subjects will not be compensated for their participation in the study.  Additionally, the study 
will require no additional hospital or clinic visits beyond those that are standard of care for the 
lumbar spinal fusion surgery, so there will be no anticipated additional expenses for travel time 
or lost wages. 
 
9.  Potential Risks: Vulnerable populations are excluded from this study.  If a subject chooses 
not to participate in this study, they will receive IV PCA Hydromorphone and oral (by mouth) 
analgesics as is currently the standard of care at Zale Lipshy University Hospital.   
 
• Risks of the Epidural Analgesia 
There is possibility of a non-working epidural catheter, infection, damage to nerves, arteries, 
and veins. An inadvertent placement of epidural catheter may result in systemic toxicity of local 
anesthetics (bupivacaine) inadequate pain relief, or epidural hematoma with neurological 
complications.  Other side effect of epidural catheter placement includes dural puncture which 
may cause spinal headache. Epidural catheter will be placed by the surgeons under direct 
visualization at the end of the surgery.  The surgical wound will be closed after ensuring the 
surgical field is dry and the catheter is not in the subarachnoid space. Subjects   with dura 
damage during surgery will be excluded from the study.   
 
1-Infection 
Epidural catheter may cause infection such as meningitis. The incidence is very rare and 
increased after the 3 days of the epidural catheter placement. Infection will be monitored 
during postoperative period per hospital protocol. High risk subjects such as 
immunocompromised will not be enrolled to the study.   
 
2-Local anesthetic (bupivacaine) toxicity  
There is minimal risk of local anesthetic (bupivacaine) toxicity due to advert injection of local 
anesthetic into the blood vessel. If injected into a blood vessel, large amounts of local anesthetic 
(bupivacaine) can cause tinnitus, lightheadedness, dizziness, tachycardia, blurred vision, and 
numbness around mouth, seizures, hypotension, and even cardiac arrest. If it is happen 
appropriate supportive treatment will be given. The risk is high as the local anesthetic is infused 
in the raw surgical area that is hyperemic. The epidural catheter will be placed by an 
experienced surgeon under direct visualization and bupivacaine will be given a small amount 
via automatic pump, therefore the risk is minimal. The surgical wound will be closed after 
ensuring the surgical field is dry and the catheter is not in the subarachnoid space.  
 
3- Bleeding and Epidural Hematoma 


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Epidural catheter placement may cause epidural bleeding and hematoma. There is also 
possibility of neurological damage as a consequence of epidural hematoma. Epidural catheter 
placement in patients with a history of use of anti-coagulant or anti-platelet therapies will be 
done following the American Society of Regional Anesthesia and Pain Medicine (ASRA) current 
guidelines—“Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic 
Therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based 
Guidelines”.   Additionally, epidural catheters will be removed by the Acute Pain Service per 
protocol regarding patients who receive anti-coagulant or anti-platelet therapies post-
operatively.  These guidelines are followed to minimize the risk of epidural hematoma.  
 
4- Risk of Epidural Opioid (Fentanyl):  
Epidural fentanyl may cause common side effects of opioids including nausea, vomiting, 
pruritus (itching), drowsiness, urinary retention, and constipation. It may also decrease in 
breathing frequency (breathing rate <8 times/min), but low doses of fentanyl will be given very 
slowly and continuously. Because the doses of fentanyl will be given very low and investigators 
don't expect a decrease in the amount of respirations. The advert injection of fentanyl causes 
decreasing level of consciousness, hypotension, and respiratory depression.   
 
5-Risk of Epidural Bupivacaine   
Epidural bupivacaine may cause transient numbness or weakness, paralysis of lower 
extremities. Some degree of numbness and paresthesia expected but not motor block. 
Bupivacaine will be used low dose (0.0625%) to prevent development of motor block. 
  
• Risk of IV Patient-Controlled Analgesia: 
IV patient-controlled opioid analgesia is part of the standard treatment for post-operative pain 
after surgery. Patient will receive baseline infusion and additionally opioid as needed.  
 
1-Risk of Intravenous Catheter: 
If the intravenous cannula is not placed correctly, it may cause rupture of vessels and blood 
leaks into the surrounding tissue. Using this misplaced cannula also causes extravasation of IV 
fluid and the drug, which leads to edema, tissue damage, and pain. There is risk of insertion 
site infection which may lead phlebitis, cellulitis and even sepsis.  
  
2-Risk of Hydromorphone:  
Hydromorphone has side effects including nausea, vomiting, difficulty in urination, pruritus 
(itching), drowsiness, and constipation. It may also cause sedation and respiratory depression 
but low doses will be given very slowly and continuously. 
 
• Psychological Stress 
Some of the questions related to the study may make the subject feel uncomfortable.  Subjects 
may refuse to answer any of the questions, or take a break or stop participation in the study at 
any time. 
 
• Loss of Confidentiality 
Any time information is collected; there is a potential risk of loss of confidentiality.  Every effort 
will be made to keep subjects information confidential and secure as detailed below. 
 


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10.  Costs to the Subject – We foresee no additional costs to the subjects. IV PCA is standard 
of care and epidural analgesia has been used for selected spine surgery cases at Zale 
University Hospital as a treatment option for postoperative pain management.  
 
11.  Subject Safety and Data Monitoring: 
Since this is a single center study involving standard analgesic techniques, there is no safety 
monitoring board for this protocol.  Data will be evaluated at the completion of the study to 
determine the efficacy and safety of epidural analgesia relative to control.  Protocol violations 
and adverse events will be recorded and reported to the IRB during the study. 
 
All unexpected or serious adverse events will be reported to the UTSW IRB office within 24 
hours of their discovery. The PI will review aggregated adverse events after 25 subjects have 
been enrolled. 
 
12.  Procedures to Maintain Confidentiality:   
All subjects will be identified by a numerical code (case # 01, case # 02…. etc.) during gathering 
and reporting the information.   Study records will be kept confidential as required by law.  
Federal Privacy Regulations provide safeguards for privacy, security, and authorized access.  
Except when required by law, subjects will not be identified by name, social security number, 
address, telephone number or any other direct personal identifier in study records disclosed 
outside of the UT Southwestern Medical Center.  All research records will be locked in offices in 
the Departments of Anesthesiology and Pain Management, and Neurosurgery, , or stored on 
secure UT Southwestern computer servers.  Only research staff listed as key personnel will be 
able to access these records. 
 
13. Potential Benefit: 
Subjects will not directly benefit from participation in this protocol other than receiving pain 
management from the Acute Pain Service (in both arms of the study).  If the use of epidural 
analgesia is shown to be associated with better analgesia and postoperative outcomes, the 
potential benefits to future patients could be significant. 
 
The results of this study will be used to optimize spine care at UTSW Zale University Hospital.  
Publication of study findings will contribute to the care of spine surgery patients in general.   
 
Intended/Potential Use of Study Findings:  The results of this study will be used to guide the 
analgesic care of patients undergoing lumbar spinal fusion surgery.  Results will be published 
in a peer-reviewed medical journal. 
 
14. Biostatistics  
The primary outcome for this study is the post-operative pain score (Visual Analogue Scale) at 
24 hours.  The study is powered to detect a large effect size (Cohen’s d = 0.8) in VAS pain score 
using a one-sided alternative with a type I error rate of 0.025 and power of 80%.  To achieve 
this, a total of 52 patients are needed to be randomized in the two study groups.  Assuming a 
10% loss of patients before completion of surgery, a total of 58 patients will be randomized. 
 
Continuous variables will be summarized using mean and standard deviation or median and 
inter-quartile range (IQR) while categorical variables will be summarized using frequency and 


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percentages.  Comparison of the two study groups will be made using standard parametric or 
non-parametric statistical analyses as appropriate. 
 
15. References: 
 
1) Parker et al.  Effect of Minimally Invasive Technique on Return to Work and Narcotic Use 
Following Transforaminal Lumbar Inter-body Fusion: A Review. Professional Case 
Management 2012; Vol. 17, No. 5: 229-235. 
2) Block et al. Control of postoperative pain by epidural catheter using nerve stimulation 
in thoracic surgery. JAMA, 2003; 290(18): 2455-63. 
3) Abrishamkar, Eshraghi N et al. Analgesic effects of ketamine infusion on postoperative 
pain after fusion and instrumentation of the lumbar spine: a prospective randomized 
clinical trial. Med Arh 2012; 66(2): 107-10. 
4) Sekar et al. Preemptive Caudal Ropivacaine: An Effective Analgesic during Degenerative 
Lumbar Spine Surgery. The Spine Journal 4 (2004): 261-264. 
5) Cohen et al. Postoperative Pain Control After Lumbar Spine Fusion: Patient Controlled 
Analgesia Versus Continuous Epidural Analgesia. Spine. 1997, 22(16): 1892-1896. 
6) Sucato Allison D; Emily E; Fay S. Postoperative Analgesia Following Surgical Correction 
for Adolescent Idiopathic Scoliosis: A Comparison of Continuous Epidural Analgesia and 
Patient-Controlled Analgesia.  Spine 2005; 30, No. 2. 
7) Kluba T, Hofmann F et al. Efficacy of post-operative analgesia after posterior lumbar 
instrumented fusion for degenerative disc disease: a prospective randomized 
comparison of epidural catheter and intravenous administration of analgesics. 
Orthopedic Reviews 2010; 2:e9, 27-30. 
8) Yukawa et al. A Prospective Randomized Study of Preemptive Analgesia for 
Postoperative Pain in the Patients Undergoing Posterior Lumbar Interbody Fusion. 
Spine 2005; 30, No. 21. 
9) Ilangovan V, Vivakaran TT, Gunasekaran D, Devikala D. Epidural tramadol via 
intraoperatively placed catheter as a standalone analgesic after spinal fusion 
procedure: An analysis of efficacy and cost. J Neurosci Rural Pract. 2017; 8(1): 55 - 59. 
10) Li Y, Lu S, Ma SC, Fan HW, Zhao GQ. Effects of patient-controlled epidural analgesia and 
patient-controlled intravenous analgesia on analgesia in patients undergoing spinal 
fusion surgery. Am J Ther 2016; 23(6): e1806-e1812. 
11) Lu S, Ma SC, Wang YY, Zhu ZH, Fan HW, Zhao GQ. Comparison of pain relief between 
patient-controlled epidural analgesia and patient-controlled intravenous analgesia for 
patients undergoing spinal fusion surgeries. Arch Orthop Trauma Surg 2015; 135: 1247–
1255.  
12) Klatt JW, Mickelson J, Hung M, Durcan S, Miller C, Smith JT.  A randomized prospective 
evaluation of 3 techniques of postoperative pain management after posterior spinal 
instrumentation and fusion. Spine 2013; 38: 1626–1631. 
13) Cassady JF Jr, Lederhaas G, Cancel DD, Cummings RJ, Loveless EA. A randomized 
comparison of the effects of continuous thoracic epidural analgesia and intravenous 
patient-controlled analgesia after posterior spinal fusion in adolescents. Reg Anesth Pain 
Med 2000; 25:246–253 
14) Turner A, Lee J, Mitchell R, Berman J, Edge G, Fennelly M. The efficacy of surgically placed 
epidural catheters for analgesia after posterior spinal surgery. Anaesthesia 2000; 55: 
370–373. 


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15) Cata JP, Noguera EM, Parke E, Ebrahim Z, Kurz A, Kalfas I, Mascha E, Farag E. Patient-
controlled epidural analgesia (PCEA) for postoperative pain control after lumbar spine 
surgery. J Neurosurg Anesthesiol 2008; 20(4): 256–260 
16) Schenk MR, Putzier M, Kugler B, et al. Postoperative analgesia after major spine surgery: 
patient-controlled epidural analgesia versus patient-controlled intravenous analgesia. 
Anesth Analg 2006; 103: 1311-7. 
17) Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, et al. Quality of 
postoperative pain using an intraoperatively placed epidural catheter after major 
lumbar spinal surgery. Anesthesiology 2004; 101: 175–80. 
18) Cohen BE, Hartman MB, Wade JT, et al. Postoperative pain control after lumbar spine 
fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine 1997; 
22: 1892–7. 
 

ICF_001.pdf: 
Informed Consent Form cover page 
 
 
 
Official title:  A Comparison of Epidural and Intravenous 
Patient Control Analgesia Following Lumbar Spinal Fusion 
Surgery: A Prospective Randomized Study 
 
NCT number: NCT03115151 
IRB Approved date: 03-08-2019 
 


STU092016-061, Kandil, Form E - Epidural, Mod_14, 03-08-19 
 
 
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DO NOT DISCLOSE 
 
 
The University of Texas Southwestern Medical Center  
Parkland Health & Hospital System 
Children’s Medical Center 
Retina Foundation of the Southwest 
Texas Scottish Rite Hospital for Children 
Texas Health Presbyterian Hospital Dallas 
 
CONSENT TO PARTICIPATE IN RESEARCH 
 
 
Title of Research:  
A Comparison of Epidural and Intravenous Patient-
Controlled 
Analgesia 
Following 
Lumbar 
Spinal 
Fusion Surgery:  A Prospective Randomized Study 
 
 
Funding Agency/Sponsor: 
Department of Anesthesiology and Pain Management, 
and Department of Neurosurgery UT Southwestern 
Medical Center 
 
Study Doctors: 
Enas Kandil, M.D., Stephanie Jones M.D., Carlos A. 
Bagley, M.D. David McDonagh M.D. 
 
   
 
 
You may call these study doctors or research personnel during regular office hours at 
(214) 648-0593.  At other times, you may call them at 214-786-4248 and ask to speak 
with someone about the study. 
 
Instructions: 
Please read this consent form carefully and take your time making a decision about 
whether to participate.  As the researchers discuss this consent form with you, please 
ask him/her to explain any words or information that you do not clearly understand.  The 
purpose of the study, risks, inconveniences, discomforts, and other important 
information about the study are listed below.  If you decide to participate, you will be 
given a copy of this form to keep. 
 
Why is this study being done? 
This study is being done to compare quality of pain relief of two routes of pain 
medication administration through your vein (intravenous patient-controlled analgesia) 
or by your back (Lumbar Epidural Analgesia) after spine surgery.   
 
Why is this considered research?  
This is a research study because pain treatment following spine surgery is difficult to 
Study ID: STU 092016-061   Date Approved: 3/8/2019


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manage and treating the pain with intravenous (through vein) opioid analgesics often 
has many side effects including nausea, vomiting, difficulty in urination, pruritus 
(itching), drowsiness, constipation or difficulty breathing.  Pain medication can be given 
through the vein or by way of an epidural. The researchers are interested in learning 
which route is more effective for treating pain after lumbar spinal fusion surgery. 
 
The following definitions may help you understand this study:  
 Randomization means you will be placed by chance (like a flip of a coin) in one 
of the two study groups.  
 Researcher means the study doctor or research personnel at the University of 
Texas Southwestern Medical Center at Dallas and its affiliated hospitals. 
 Patient-Controlled Analgesia (PCA): A PCA mean pain medication is delivered   
using a pump which is connected directly to a patient's vein or to the epidural 
space and contains a syringe of pain medication as prescribed by a doctor.  
 Patient-Controlled Analgesia Pump is a computerized smart pump used to 
deliver a small, constant flow of pain medication. You can also give pain 
medication as needed by pushing a button connected to the pump. 
 
Why am I being asked to take part in this research study? 
You are being asked to take part in this study because you are having a lumbar spinal 
fusion surgery. 
 
Do I have to take part in this research study? 
No.  You have the right to choose whether you want to take part in this research study.  
If you decide to participate and later change your mind, you are free to stop participation 
at any time. If you decide not to take part in this research study it will not change your 
legal rights or the quality of health care that you receive at this center. 
 
How many people will take part in this study? 
About 58 people will take part in this study at UT Southwestern Zale Lipshy University 
Hospital.   
 
What is involved in the study? 
If you volunteer to take part in this research study, you will be asked to sign this consent 
form and will have the following tests and procedures.   
 
Screening Procedures 
To help decide if you qualify to be in this study, the researchers may ask you questions 
about your health, including medications you take and any surgical procedures you 
have had. 
 
Group Assignment 
Once the researchers determine you can take part in this study, you will be assigned 
randomly (like a flip of a coin) to receive either epidural analgesia or intravenous 
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analgesia. Both epidural analgesia and intravenous analgesia are considered as 
standard of care for spine surgery. 
 
Both routes of pain medication administration are considered standard of care, one of 
which you will receive regardless of study participation. The placement of the epidural 
catheter will be performed by the surgeon at the end of your planned lumbar fusion 
surgery, while intravenous analgesia will be performed by an anesthesiologist of the 
Acute Pain Service (APS) immediately following surgery in the Post Anesthesia Care 
Unit (PACU). The APS will manage intravenous (IV) and the epidural analgesia 
following surgery.  
 
In addition, you will also receive regular oral pain medications regardless of study 
participation. The group you will be assigned to will be decided randomly.   
  
Procedures and Evaluations during the Research 
If you agree to be in this study, you will receive your pain medication after surgery either 
via epidural catheter or your vein. 
 
Intravenous Patient-Controlled Analgesia will be performed by anesthesiologists with 
the Acute Pain Service using automatic drug infusion pump. A morphine-like pain killer 
(hydromorphone) will be given through your vein with this infusion pump. 
Hydromorphone will be given very slowly and continuously. If you have pain, you can 
also receive hydromorphone by pushing a button, which is connected to the pump.   
  
Epidural Patient-Controlled Analgesia: The epidural space is the area surrounding 
the fluid-filled sac around your spinal cord in your back. Your surgeon will place the 
epidural catheter during your surgery.  The epidural catheter is a very thin tube and will 
be placed in the epidural space, the area between a membrane and vertebral wall 
(outermost of part of spinal column).  
 
Following surgery, the Acute Pain Service anesthesiologist will give Bupivacaine and 
fentanyl combination very slowly and continuously through the epidural catheter by 
using an automatic pump. Bupivacaine is a numbing medication, which is used for 
regional anesthesia. Fentanyl is a fast and rapid acting morphine type medication. They 
both will be used at very low amounts.   
 
You will fill out questionnaires about state of your mind, worry (anxiety), and 
characteristics of your pain before the surgery and daily or at follow-up visit.  It will take 
about 5 minutes.  
 
We will ask you daily to make a mark on a pain assessment paper. Each assessment 
should take no more than 5 minutes.      
 
How long can I expect to be in this study? 
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This study will take place during your hospital stay and until the first follow-up office 
visit. It may take approximately 50 days.   
 
You can choose to stop participating for any reason at any time.  However, if you decide 
to stop participating in the study, we encourage you to tell the researchers. 
 
What are the risks of the study? 
Because of your participation in this study, you are at risk for the following side effects: 
bleeding, hematoma, infection at the site of medication administration, although they are 
extremely rare. You should discuss these with the researchers and your regular health 
care provider.  
 
 Risk of Epidural Analgesia 
There is possibility of a non-working epidural catheter, inadequate pain relief, infection, 
damage to nerves, arteries, and veins. An inadvertent placement of the epidural 
catheter may result in absorption of numbing medication (bupivacaine) and opioid 
(fentanyl) into the spinal sack, which covers your brain (intrathecal). If medications pass 
into the intrathecal area, you may have weakness (transient paralysis) in your lower 
limb and hypotension. If medications move to your blood stream, you may have side 
effects of numbing medication (bupivacaine) such as local anesthetic toxicity and opioid 
(fentanyl) side effects such as drowsiness, pruritus, and urinary retention.   
 
Other side effect of epidural catheter placement includes puncture of the outer most 
layer of the brain membranes (dura mater) which may cause headache.  The epidural 
catheter will be placed by the surgeons under direct visualization at the end of the 
surgery.   
 
1-Infection 
The epidural catheter may cause an infection such as meningitis. The incidence is very 
rare and increased after 3 days of the epidural catheter placement. Evidence of 
infection will be monitored during postoperative period per hospital protocol. The 
epidural catheter will be removed at 72 hrs. after surgery. 
  
2. Local anesthetic (bupivacaine) toxicity 
There is a rare but serious potential side effect related to the numbing medication 
(bupivacaine) itself. If numbing medication is given into a blood vessel, in large 
amounts, it can cause nausea, vomiting, tinnitus, lightheadedness, dizziness, 
drowsiness, tachycardia (increased heart rate), blurred vision, and numbness around 
mouth, hypotension, seizures and even cardiac arrest.  There is minimal risk of local 
anesthetic toxicity with an advert injection into the blood vessel while giving pain 
medication. The epidural catheter will be placed by an experienced surgeon and 
bupivacaine will be given in a small amount via automatic pump, therefore the risk is 
minimal.  
 
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There is the possibility of local anesthetic and opioid absorption from the raw surgical 
area. The surgical wound will be closed after ensuring the surgical field is dry and the 
catheter is in epidural space.  
 
3. Risk of bleeding 
Epidural catheter placement may cause epidural bleeding and hematoma. There is also 
possibility of neurological damage as a consequence of an epidural hematoma. There 
may be a bleeding risk into the epidural space if you have a history of receiving therapy 
against blood clotting.  The epidural catheter will be placed by an experienced surgeon 
during your surgery. The Acute Pain Service will remove the epidural catheters very 
carefully.  
 
4. Risk for epidural opioid (fentanyl) 
Epidural fentanyl may cause common side effects of opioids including nausea, vomiting, 
pruritus (itching), drowsiness, urinary retention, and constipation. It may also decrease 
your breathing frequency to less than 8 times in a minute (normal is 12-20 breaths per 
minute), but low doses of fentanyl as opioids will be given very slowly and continuously 
through epidural catheter. Because the dose of opioids in the study is very low, the 
investigators don't expect a decrease in respirations and common side effects of opioids 
such as nausea, vomiting, and constipation. 
 
5-Risk of Epidural Bupivacaine  
Epidural bupivacaine may cause transient numbness or weakness, paralysis of lower 
extremities. Some degree of numbness and paresthesia (burning or prickly sensation) is 
expected, but not severe weakness in your lower limbs. Bupivacaine will be used in low 
doses (0.0625%) to prevent development of weakness. 
 
 Risk of intravenous Patient-Controlled Analgesia  
1. Infection and vessel damage:  
If the intravenous cannula is not placed correctly, it may cause damage of vessels and 
blood leaks into the surrounding tissue. Using this misplaced cannula also causes 
edema, damage of surrounding tissue and pain. There is risk of infection, which may 
lead to vein infection (phlebitis), tissue infection (cellulitis) and even sepsis (infection of  
all organs).  
 
2. Risk of hydromorphone  
You will receive hydromorphone as opioid via your vein as a part of the treatment for 
pain after surgery. Hydromorphone has side effects including nausea, vomiting, difficulty 
in urination, pruritus (itching), drowsiness, constipation. It may also decrease your 
breathing frequency, but low doses of hydromorphone will be given very slowly and 
continuously through your vein. Because the dose of opioids in the study is very low and 
investigators don't expect a decrease in respirations. 
 
 Psychological Stress 
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Some of the questions we will ask you as part of this study may make you feel 
uncomfortable.  You may refuse to answer any of the questions, take a break or stop 
your participation in this study at any time. 
 
 Loss of Confidentiality 
Any time information is collected; there is a potential risk for loss of confidentiality.  
Every effort will be made to keep your information confidential; however, this cannot be 
guaranteed.   
 
 Other Risks 
There may possibly be other side effects that are unknown at this time. If you are 
concerned about other, unknown side effects, please discuss this with the researchers. 
 
How will risks be minimized or prevented?   
The epidural catheter will be placed by the experienced surgeon with epidural catheter 
placements. The Acute Pain Service anesthesiologist will perform intravenous patient-
controlled analgesia. They will use an existing venous catheter to connect the automatic 
pain pump to your vein.  
 
To prevent the risk of serious side effects associated with local anesthetic overdose, 
bupivacaine will be given very slowly in low dose via the epidural catheter at the volume 
limited to those that are known to be safe.  Before starting the epidural infusion, an 
experienced anesthesiologist will also check placement of the catheter.  
 
You will be monitored closely postoperatively and there will always be immediate 
therapy available for any serious side effects.   
 
What will my responsibilities be during the study?   
While you are part of this study, the researchers will follow you closely to determine 
whether there are problems that need medical care.  It is your responsibility to do the 
following: 
• Ask questions about anything you do not understand. 
• Follow the researchers’ instructions. 
• Let the researchers know if your telephone number or address changes. 
• Tell the researchers before you take any new medication, even if it is prescribed by 
another doctor for a different medical problem or something purchased over the 
counter. 
 Report to the researchers any injury or an illness while you are on study even if you do 
not think it is related.  
 
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? 
Yes.  You will be told if any new information becomes available during the study that 
could cause you to change your mind about continuing to participate or that is important 
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to your health or safety. 
 
 
What should I do if I think I am having problems? 
If you have unusual symptoms, pain, or any other problems while you are in the study, 
you should report them to the researchers right away.  Telephone numbers where they 
can be reached are listed on the first page of this consent form. 
 
If you have a sudden, serious problem, like difficulty breathing or severe pain, go to the 
nearest hospital emergency room, or call 911 (or the correct emergency telephone 
number in your area).   
 
What are the possible benefits of this study? 
If you agree to take part in this study, there may or may not be direct benefits to you.  
However, the researchers cannot guarantee that you will benefit from participation in 
this research. 
 
You may need less pain medications to control your pain after your surgery. 
Investigators are expecting better pain control and less opioid-related side effects by 
using epidural route for pain treatment.  
 
We hope the information learned from this study will benefit others having lumbar fusion 
surgery in the future.  Information gained from this research could lead to better pain 
control after surgery.  
 
What options are available if I decide not to take part in this research study? 
You do not have to participate in this research to receive care for your medical problem. 
Instead of being in this study, you will receive the regular postoperative pain regimen via 
vein, epidural, or by mouth. Please talk to the researchers or your personal doctor about 
these options.  
 
Will I be paid if I take part in this research study? 
No. You will not be paid to take part in this research study. There are no funds available 
to pay for parking expenses, transportation to and from the research center, lost time 
away from work and other activities, lost wages, or childcare expenses. 
 
Will my insurance provider or I be charged for the costs of any part of this 
research study? 
No. Neither you, nor your insurance provider, will be charged for anything done only for 
this research study (i.e., the Screening Procedures or Monitoring/Follow up Procedures 
described above).  Both intravenous and epidural patient-controlled analgesia are 
standard of care. You will receive one of them regardless of participation to the study. 
 
However, the standard medical care for your condition (care you would have received 
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whether or not you were in this study) is your responsibility (or the responsibility of your 
insurance provider or governmental program). You will be charged, in the standard 
manner, for any procedures performed for your standard medical care. 
What will happen if I am harmed as a result of taking part in this study? 
It is important that you report any illness or injury to the research team listed at the top 
of this form immediately. Compensation for an injury resulting from your participation in 
this research is not available from the University of Texas Southwestern Medical Center 
at Dallas. 
 
You retain your legal rights during your participation in this research. 
 
Can I stop taking part in this research study? 
Yes.  If you decide to participate and later change your mind, you are free to stop taking 
part in the research study at any time. 
 
If you decide to stop taking part in this research study, it will not affect your relationship 
with the UT Southwestern staff or doctors.  Whether you participate or not will have no 
effect on your legal rights or the quality of your health care. 
 
If you are a medical student, fellow, faculty, or staff at the Medical Center, your status 
will not be affected in any way. 
 
If I agree to take part in this research study, can I be removed from the study without my 
consent? 
Yes.  The researchers may decide to take you off this study if: 
• Your medical problem remains unchanged or becomes worse. 
• The researchers believe that participation in the research is no longer safe for you. 
• The researchers believe that other treatment may be more helpful. 
 
Will my information be kept confidential? 
Information about you that is collected for this research study will remain confidential 
unless you give your permission to share it with others or if we are required by law to 
release it.  You should know that certain organizations that may look at and/or copy 
your medical records for research, quality assurance, and data analysis include: 
 
• The UT Southwestern Institutional Review Board.  
 
In addition to this consent form, you will be asked to sign an "Authorization for Use and 
Disclosure of Protected Health Information."  This authorization will give more details 
about how your information will be used for this research study, and who may see 
and/or get copies of your information. 
 
Are there procedures I should follow after stopping participation in this research? 
No, we only encourage you to immediately inform the research personnel that you wish 
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to withdraw from the research. 
 
 
Whom do I call if I have questions or problems? 
For questions about the study, contact Enas Kandil at (214) 64 5-0629 during regular 
business hours and at 214-786-4248 after hours and on weekends and holidays.   
 
For questions about your rights as a research participant, contact the UT Southwestern 
Institutional Review Board (IRB) Office at 214-648-3060. 
 
SIGNATURES: 
 
YOU WILL BE GIVEN A COPY OF THIS CONSENT FORM TO KEEP. 
 
You understand that a copy of this signed consent document, information about this 
study, and the result of any test or procedure that may affect your medical care, may be 
included in your medical record. Information in your medical record will be available to 
heath care providers and authorized persons including your insurance company. 
 
Your signature below certifies the following: 
 You have read (or been read) the information provided above. 
 You have received answers to all of your questions and have been told who to 
call if you have any more questions. 
 You have freely decided to participate in this research. 
 You understand that you are not giving up any of your legal rights. 
 You understand that a copy of this signed consent document, information about 
this study, and the results of any test or procedure that may affect your medical 
care, may be included in your medical record.  Information in your medical 
record will be available to health care providers and authorized persons 
including your insurance company. 
 
____________________________________________ 
 
 
Name of Participant (Printed) 
 
 
____________________________________________ 
________ 
_______ AM / PM 
Signature of Participant 
Date 
Time 
 
___________________________________________ 
 
 
Name of Person Obtaining Consent (Printed) 
 
 
 
 
____________________________________________ 
________ 
_______ AM / PM 
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Signature of Person Obtaining Consent 
Date 
Time 
 
Study ID: STU 092016-061   Date Approved: 3/8/2019