Clinical trial NCT04258631
Conditions: Malignant Female Reproductive System Neoplasm
Sponsor: Mayo Clinic
Start date: 2020-07-09; Completion date: 2023-08-08
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate if no additional intervention is noninferior to intrathecal analgesia (ITA) for postoperative pain experience 24 hours after surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway which includes incisional liposomal bupivacaine (ILB).

II. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after laparotomy for gynecological malignancy.

III. Report the impact of ITA use on cost. IV. Validate the Quality of Recovery (QOR)-15 in our population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine.

ARM II: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone intrathecally (IT).

Arms: arm 1: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. arm 2: Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT.
Interventions: intervention 1: Hydromorphone intervention 2: Laparotomy intervention 3: Liposomal Bupivacaine intervention 4: Questionnaire Administration
Intervention descriptions: intervention 1: Given IT intervention 2: Undergo laparotomy intervention 3: Drug intervention 4: Ancillary studies

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
19-010500 (MC2061) 
 
Wound Infiltration with Liposomal Bupivacaine with or without 
Intrathecal Analgesia in Laparotomy for Gynecological 
Malignancy: A Randomized Controlled Trial 
 
NCT04258631 
 
 
Document Date: 01/07/2021 


Wound Infiltration with liposomal bupivacaine with or without 
intrathecal analgesia in laparotomy for gynecological malignancy: A 
Randomized Controlled Trial 
Principal Investigator:  Sean C. Dowdy, M.D. 
Co-Investigators: 
Katherine W. Arendt, M.D. 
Christopher J. Jankowski, M.D., M.B.O.E. 
Deepa Maheswari Narasimhulu, M.B.B.S. 
Michelle A. Ochs Kinney, M.D. 
Protocol Version 2.0 – 01.07.2021 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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A. Background: 
Enhanced recovery after surgery (ERAS) has become the standard of care for patients undergoing 
surgery for gynecological malignancies after the ERAS guidelines for gynecologic oncology were widely 
disseminated in 2016.1,2 Regional analgesia can be a part of a multimodal analgesic regimen leading to 
opioid-sparing effects.3  While epidurals are effective for pain control, they may slow postoperative 
mobility, delay return of bowel function, prolong the need for urinary catheters, result in transient 
hypotension, and may be ineffective in as many as 50% of patients.4, 5 Alternate opioid sparing 
modalities include intrathecal analgesia and incisional local anesthetic infiltration.  
Intrathecal analgesia (ITA) has been shown to shorten time to return of bowel function and length of 
hospital stay when compared to epidural analgesia.5 Intrathecal analgesia is known to be effective after 
cesarean delivery;6 preservative free morphine in a dose of 100 to 200µg is the most commonly used 
agent. Following a national shortage of preservative-free morphine, intrathecal hydromorphone has 
been explored as a potential alternative for postoperative analgesia. Hydromorphone is more lipophilic 
than morphine which may allow for a favorable side effect profile.7, 8 Intrathecal analgesia is being 
incorporated into ERAS protocols to decrease postoperative opioid consumption. 
In our practice, wound infiltration with liposomal bupivacaine is the cornerstone of treatment of early 
postoperative pain within our ERAS pathway, and resulted in a reduction in patient-controlled analgesia 
from 33.35 to 4.1% (P<.001) in patients undergoing laparotomy and complex cytoreduction for ovarian 
cancer.9 The advantages of wound infiltration are that it is quick, simple, inexpensive, and consistently 
effective. Intrathecal analgesia is currently used in less than 1% of our patients.   
Given that visceral pain which can be significant in tumor debulking is not targeted by incisional 
bupivacaine, combining ITA with incisional liposomal bupivacaine (ILB) to provide more intensive pain 
relief in the first 24 hours is a viable option. However, it is unclear if patient experience with pain 
management is improved with ITA given that opioid related side effects (nausea, vomiting, itching) as 
well as rare adverse events related to spinal injections (postural puncture headache) can occur. 
Additionally, ITA is invasive and expensive. The purpose of this investigation is to evaluate whether ILB is 
non-inferior to a combination of ITA and ILB for management of postoperative pain after laparotomy for 
gynecological malignancy within an established enhanced recovery pathway using the Overall Benefit of 
Analgesia Score (OBAS) as our primary outcome10. Additionally, we will evaluate cumulative 24 hour 
postoperative morphine milligram equivalents (MME) consumption, pain scores, length of stay, cost, 
and patient satisfaction as secondary outcomes.  
B. Hypothesis and Aims 
Hypothesis:  Among women undergoing laparotomy for gynecological malignancy, the pain experience 
(as measured by the OBAS) of those randomized to no additional intervention will be non-inferior to 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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that of patients randomized to ITA with 150mcg of hydromorphone within an established enhanced 
recovery pathway which includes incisional ILB (in both arms). 
Specific Aims  
1. Evaluate if no additional intervention is noninferior to ITA for postoperative pain experience 24 hours after 
surgery after laparotomy for gynecological malignancy within an established enhanced recovery pathway 
which includes ILB. 
2. Evaluate the effect of intrathecal analgesia on patient satisfaction with postoperative analgesia after 
laparotomy for gynecological malignancy. 
3. Report the impact of ITA use on cost.  
4. Validate the QOR-15 in our population 
 
C. Research plan and methods: 
 
C.1   Study design: Randomized controlled study  
 
Randomization:  
1. Stratified by:  
a. Likelihood of bowel resection ≥50% or <50% as assessed by surgeon  
b.  Planning to use NSAIDs vs not planning to use NSAIDs 
2. Allocation ratio- 1:1 
3. Allocation sequence- permutated bock randomization with varying block sizes ( Provided by statistician in 
the Department of Biostatistics and Informatics) 
Blinding: None 
Allocation concealment method: web-based 
 
C.2   Population, intervention, comparator, and outcomes  
 
Population:  
Women undergoing laparotomy for gynecological malignancy 
Inclusion: age >18yo and ≤80yo, elective surgery for suspected (based on consulting surgeon’s opinion- 
imaging, lab, path) gynecological malignancy, ERAS protocol 
Exclusion: 
1. Inability to read or understand English 
2. Prehospitalization narcotic use if weekly average daily oral morphine equivalent of >20 mg.  
3. Chronic pain syndromes such as fibromyalgia. 
4. Extensive surgery planned (surrogate for postop pain): Planned ICU admission, abdominoperineal 
resection, exenteration, use of IORT, HIPEC 
5. Contraindication to neuraxial analgesia:  
a. Coagulopathy 
i. INR >1.2 Current or predicted after surgery (e.g. planned right hepatic resection) 
ii. Thrombocytopenia.  plts <100. 
iii. Hemophiliac disease states (hemophilia, von Willebrand disease, etc.) 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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iv. Patients receiving antithrombotic or thrombolytic therapy are excluded according to 
the ASRA guidelines (Reference: 
https://rapm.bmj.com/content/rapm/43/3/263.full.pdf) 
b. Localized infection at the potential site of injection 
c. Significant developmental or structural spinal abnormalities that would preclude a safe 
spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and 
active lumbar radiculopathy. 
6. Patients with stage 4 or 5 kidney disease (GFR less than 30 ml/min per 1.73 m2). 
7. Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics 
8. Current pregnancy 
 
Intervention: ITA with 150mcg of hydromorphone in addition to ILB. For patients randomized to ITA, 
injection will be performed in the O.R. 
 
Comparator: ILB 
 
Standardized perioperative anesthetic protocol (Appendix A) and postoperative protocol (Appendix B) 
will be used 
 
Outcomes:  
Primary outcome:  
Overall Benefit of Analgesia Score (OBAS): The OBAS will be administered in the form of a questionnaire to be 
filled out by the participants at baseline (preoperatively) and at 24 hours (±2 hours) postoperatively. The OBAS 
consists of 7 items that assess pain intensity, opioid-related adverse effects and patient satisfaction with pain 
management.  The composite score ranges from 0 (best) to 28 (worst). 
 
Secondary outcome: 
Cumulative 24 hour narcotic consumption, measured in morphine metabolic equivalents (MME)   
Postoperative pain scores (rest, movement) at 4, 8, 16 and 24 hours after surgery. 
Time to first analgesic request 
Use of intravenous patient-controlled analgesia 
Use of IV rescue opioids 
Length of stay 
Fluid balance: Additional fluid requirement after 24 hours of surgery, weight gain following surgery 
Cost of care 
 
Adverse events: 
Related to spinal injection: Puncture site bleeding/hematoma/infection; Spinal headache 
Related to systemic opioid effects: Itching; Nausea/vomiting; Sedation; respiratory depression 
Related to delayed recovery: Time to regular diet/Bowel movement, postoperative ileus, time to first 
ambulation, time to Foley removal, voiding dysfunction/ need for re-catheterization, readiness for discharge 
 
Cost analysis:  
OR time and surgical time 
Total and pain management related standardized costs 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
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Exploratory end point: 
QoR 1511: The QoR 15 will be administered in the form of a questionnaire to be filled out by the participants at 
24 hours (±2 hours) postoperatively for the purposes of validation. 
Sample size calculation 
The primary outcome will be the mean OBAS score measured at 24 hours postoperative. Using a non-
inferiority margin of +3 points, SD of 5, power of 90%, and 1-sided two-sample equal variance t-test with 
an alpha of 0.05, the sample size is 49 participants per group, 98 participants total. If it is determined 
after randomization that a participant will need an additional spinal injection, they will be evaluated for 
data. We will perform intention-to-treat analysis including these participants as well as per-protocol 
analysis excluding them.  Based on our data, this would be a rare situation as <1% of our current 
patients need a spinal. The sample size will be increased by 5% to maintain power for the per-protocol 
analysis. Increasing the sample size by 5% changes the sample size to 52 subjects per arm, for a total of 
104 subjects.   
We will pilot the OBAS in our target population (20 patients) in order to obtain an estimate of the SD 
specific to our patient population.  The SD reported in the literature varies from 2 to 4, so we used an SD 
of 5 in our calculation in order to be conservative. A SD of 4 would require 32 patients per group.  Prior 
to the enrollment of the first patient in this trial, a modification will be submitted to the institutional 
review board if the pilot data prompts us to modify sample size. 
Statistical analysis plan 
Data will be summarized using standard descriptive statistics by reporting mean (SD) or median (IQR) for 
continuous variables and frequency and percentages for categorical variables. Continuous variables will 
be compared between the two treatment arms using the two-sample t-test or the Wilcoxon rank sum 
test as appropriate.  Categorical variables will be compared between the two treatment arms using the 
chi-square test or the Fisher’s exact test. For the primary outcome, the mean OBAS score between the 
two groups will be presented along with the upper limit of the 95% confidence bound for the mean 
difference.  We will conclude non-inferiority if this upper limit is less than the predefined limit for non-
inferiority.  Multivariable regression models will be fit to assess for differences in outcomes if there are 
unbalanced baseline covariates in the two treatment arms. 
The primary analysis will be restricted to per-protocol patients and will mirror that of the POP-UP trial, 
which was a non-inferiority trial that evaluated the effectiveness of continuous wound infiltration in 
patients undergoing hepato-pancreato-biliary surgery.12  An intention-to-treat analysis will be 
performed as a secondary analysis based on the rationale that such an analysis in a non-inferiority trial 
might introduce bias to no difference. 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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A thorough review of the data for inconsistencies and outliers will be performed by the statistical team 
prior to the formal analysis.  Data issues will be resolved by the primary investigator and study 
coordinator.  The extent of missing data will be examined and sensitivity analyses of the primary and 
secondary outcomes will be conducted using multiple imputation if warranted.  All statistical analyses 
will be performed using SAS or R.  
 
Appendix A: Standardized perioperative anesthetic protocol 
Preoperatively:   
1. Tylenol 1000 mg po, Celebrex 200 mg po.   
2. No gabapentin administration unless patient is chronically preoperatively receiving medication.   In 
such a scenario, the patient would take their normal gabapentin dose the morning of surgery 
3. Scopolamine patches for patients at high risk for postoperative nausea and vomiting, oral caffeine 
for headache prophylaxis in caffeine users, and midazolam for anxiolysis can be administered at the 
anesthesiologist’s discretion. 
4. For those patients who will receive an intrathecal opioid (150 mcg of hydromorphone), midazolam 
and fentanyl may be administered for procedural sedation. 
Intraoperatively: 
1. The anesthetic will include induction with propofol and either succinylcholine or a non-depolarizing 
muscle relaxant. Maintenance will include volatile anesthetic/air/oxygen.  A background propofol 
infusion may be administered for postoperative nausea and vomiting prophylaxis at the 
anesthesiologist’s discretion. 
2. No dexmedetomidine, lidocaine, ketamine or remifentanil infusions. 
3. Intravenous fentanyl will be administered by the anesthesia team per the discretion of the 
anesthesiologist with a goal of no more than 500mcg fentanyl throughout the case. 
4. Postoperative nausea prophylaxis with 8 mg of IV dexamethasone, 4 mg of ondansetron, 0.625 mg 
of droperidol, Ketamine 10 mg IV at the beginning and at the end of the case.   
5. Ketorolac 15 mg IV may be given if stratified to “plan for NSAID use”at the anesthesiologist’s 
discretion. 
Postoperatively in the PACU:  
1. Fentanyl orders in the PACU:  25 mcg IV Q 2minutes prn pain 4 or greater up to 100 mcg maximum.  
If max dose of fentanyl is reached, discontinue fentanyl and give intravenous hydromorphone.  
Hydromorphone0.2 mg Q 5 minutes IV prn pain score 4-10 up to 2 mg maximum.   
2. If maximum opioids are reached in the PACU, further opioid prescribing is per the discretion of the 
anesthesiologist. 
3. Ketamine 10 mg IV may be given prn breakthrough pain at the anesthesiologist’s discretion. 
4. Rescue antiemetics, droperidol, Zofran, Kytril at the anesthesiologist’s discretion. 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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5. Caffeine 250 mg IV will only be given at the anesthesiologist’s discretion. 
6. Ditropan:  5 mg po once as needed for bladder spasms 
7. Demerol:  12.5 mg IV Q 15 min prn shivering up to 2 doses maximum. 
8. Acetaminophen 1000 mg IV or po, if 6 or more hours have passed since the preoperative dose. 
9. Ketorolac 15 mg IV may be given if stratified to “plan for NSAID use”at the anesthesiologist’s 
discretion if it was not previously given in the OR. 
 
Appendix B. Postoperative pain Management 
1. Tylenol 1000mg po every 6 hours 
2. Ketorolac 15 mg IV every 6 hours X 4 doses if stratified to “plan for NSAID use” 
3. Ibuprofen every 6 hours if stratified to “plan for NSAID use”, start 6 hours after the last Ketorolac 
dose. See table below for dose. 
Ibuprofen dose 
Weight <50 kg 
Weight 50-80 kg  
Weight >80 kg  
Age <65 
200 
600 
800 q 8 hours 
Age >65 
200 
400 
600 
 
4. Oxycodone 5mg every 4 hours PRN for moderate pain or pain score of 4-6/10. Administer if pain is 
unrelieved by Tylenol. For patients who received intrathecal analgesia, start 24 hours after 
intrathecal dose was given. 
5. Oxycodone 10mg every 4 hours PRN for severe pain or pain score of 7-10/10. Administer if pain is 
unrelieved by Tylenol. For patients that received intrathecal analgesia, start 24 hours after 
intrathecal dose was given. 
6. Dilaudid 0.4mg IV every 2 hours PRN for breakthrough pain. To be given if pain is unrelieved 30 
minutes after PRN oral medication is used; if unable to take oral pain meds; or if pain is greater than 
or equal to 7, use instead of oral pain medication. 
7. Oral intake, timing of Foley catheter removal and ambulation in accordance to ERAS protocol and 
discretion of the surgeon. 
 
 
Appendix C: OBAS questionnaire  
 
 
Appendix D: QoR 15 questionnaire 
 
 
 
 
 
 


GYN- ITA-ILB_ V2.0_ 01.07.2021 
 
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Abbreviations:  
ERAS: Enhanced recovery after surgery 
ITA: Intrathecal analgesia 
ILB : Incisional liposomal bupivacaine  
MME: Morphine milligram equivalents  
OBAS : Overall Benefit of Analgesia Score  
 
                                                          
1 Nelson G., Altman A.D., Nick A., et al: Guidelines for pre- and intra-operative care in gynecologic/oncology 
surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations–Part I. Gynecol Oncol 2016; 140: 
pp. 313-322 
2 Nelson G., Altman A.D., Nick A., et al: Guidelines for postoperative care in gynecologic/oncology surgery: 
Enhanced Recovery After Surgery (ERAS(R)) Society recommendations–Part II. Gynecol Oncol 2016; 140: pp. 323-
332 
3 Smith HJ, Leath CA 3rd, Straughn JM Jr. Enhanced Recovery After Surgery in Surgical Specialties: Gynecologic 
Oncology. Surg Clin North Am. 2018 Dec;98(6):1275-1285. 
4 Chen L.M., Weinberg V.K., Chen C., et al: Perioperative outcomes comparing patient controlled epidural versus 
intravenous analgesia in gynecologic oncology surgery. Gynecol Oncol 2009; 115: pp. 357-361 
5 Levy BF, Scott MJ, Fawcett W, Fry C, Rockall TA. Randomized clinical trial of epidural, spinal or patient-controlled 
analgesia for patients undergoing laparoscopic colorectal surgery. Br J Surg. 2011 Aug;98(8):1068-78. 
6 Kanazi GE, Aouad MT, Abdallah FW et al. The analgesic efficacy of subarachnoid morphine in comparison with 
ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. 
Anesth Analg. 2010 Aug;111(2):475-81. 
 
7 Goodarzi M. Comparison of epidural morphine, hydromorphone and fentanyl for postoperative pain control in 
children undergoing orthopaedic surgery. Paediatr Anaesth. 1999;9(5):419-22. 
 
8 Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective 
comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. 
 
9 Kalogera E, Bakkum-Gamez JN, Weaver AL et al. Abdominal Incision Injection of Liposomal Bupivacaine and 
Opioid Use After Laparotomy for Gynecologic Malignancies. Obstet Gynecol. 2016 Nov;128(5):1009-1017. 
 
10 Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, Eikermann M. Development and longitudinal 
validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J 
Anaesth. 2010 Oct;105(4):511-8. 
 
11 Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day 
case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. 
 
12 Mungroop TH, Veelo DP, Busch OR, et al. Continuous wound infiltration versus epidural analgesia after hepato-
pancreato-biliary surgery (POP-UP): A randomised controlled, open-label, non-inferiority trial. Lancet 
Gastroenterol Hepatol. 2016;1(2):105–13.  

ICF_001.pdf: 
 
 
 
 
 
 
 
19-010500 (MC2061) 
 
Wound Infiltration with Liposomal Bupivacaine with or without 
Intrathecal Analgesia in Laparotomy for Gynecological 
Malignancy: A Randomized Controlled Trial 
 
NCT04258631 
 
 
Document Date: 12/02/2022 


 
 
Approval Date:  
December 2, 2022 
Not to be used after: December 1, 2023 
 
 
IRB#:  19-010500 00            eSign AS 
Page 1 of 12 
IRB Doc. Ctrl # 10013.33 
 
 
 
 
 
 
 
Name and Clinic Number 
RESEARCH PARTICIPANT CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Study Title: Wound Infiltration with Liposomal Bupivacaine with or without Intrathecal 
Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial  
 
IRB#:  
19-010500  
 
Principal Investigator: Dr. Sean Dowdy and Colleagues 
 
 
Key Study Information 
 
 
This section provides a brief summary of the study.  It is important for you to understand why 
the research is being done and what it will involve before you decide.  Please take the time to 
read the entire consent form carefully and talk to a member of the research team before 
making your decision.  You should not sign this form if you have any questions that have not 
been answered. 
It’s Your Choice 
 
This is a research study.  Being in this research study is your choice; 
you do not have to participate.  If you decide to join, you can still stop 
at any time.  You should only participate if you want to do so. You 
will not lose any services, benefits or rights you would normally have 
if you choose not to take part. 
Research Purpose 
 
The purpose of this research is to compare two types of pain 
medication given in the operating room for women undergoing major 
abdominal surgery. One type of pain medication is infiltrated in the 
skin surrounding the abdominal incision. The other is given as an 
intrathecal (spinal) injection in combination with the first medication 
infiltrated into the skin near the abdominal incision. 
 
You have been asked to take part in this research because you are 
scheduled to undergo abdominal surgery for a suspected or diagnosed 
gynecological cancer.  
What’s Involved 
 
Study participation involves your willingness to be randomized (like 
the flip of a coin) to receive either:  
1) A standard pain medication which is infiltrated into the area 
surrounding your abdominal incision when your skin is 
surgically closed, or 


 
 
Approval Date:  
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Name and Clinic Number 
2) An intrathecal (spinal) injection of pain medication during 
surgery, in addition to a standard pain medication which is 
infiltrated into the area surrounding your abdominal incision 
when your skin is surgically closed.  
 
You will be asked to complete a short questionnaire before surgery 
and two short questionnaires approximately 24 hours after surgery. 
After finishing the questionnaires, your participation in this study will 
be complete. Your medical record will be reviewed for other 
information related to your surgery and hospitalization. 
Key Information 
All of the women enrolled in this study will receive the current 
standard medication infiltrated into the abdominal incision. Half of the 
women in this study will be assigned to receive an intrathecal (spinal) 
pain medication in addition to the standard incision medication. 
 
Possible risks with the spinal injection include puncture site bleeding, 
infection, hematoma (collection of blood within the tissue), or spinal 
headache. 
 
Benefits from participation in this research are not certain; however, 
you may experience improved pain control.  
 
All other surgical procedures, postoperative care, and pain 
management will be done as per current standard routine. There will 
not be additional study visits following your hospital stay. 
Learn More 
If you are interested in learning more about this study, read the rest of 
this form carefully. The information in this form will help you decide 
if you want to participate in this research or not.  A member of our 
research team will talk with you about taking part in this study before 
you sign this form.  If you have questions at any time, please ask us. 
 
 
 


 
 
Approval Date:  
December 2, 2022 
Not to be used after: December 1, 2023 
 
 
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Name and Clinic Number 
 
Making Your Decision 
 
 
Taking part in research is your decision.  Take your time to decide.  Feel free to discuss the study 
with your family, friends, and healthcare provider before you make your decision.  Taking part in 
this study is completely voluntary and you do not have to participate. 
 
If you decide to take part in this research study, you will sign this consent form to show that you 
want to take part. We will give you either a printed or electronic copy of this form to keep. A 
copy of this form will be put in your medical record. 
 
For purposes of this form, Mayo Clinic refers to Mayo Clinic in Arizona, Florida and Rochester, 
Minnesota; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals, and 
entities. 
 
 


 
 
Approval Date:  
December 2, 2022 
Not to be used after: December 1, 2023 
 
 
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Name and Clinic Number 
 
Contact Information 
 
 
If you have questions about … 
You can contact … 
 Study tests and procedures 
 Materials you receive 
 Research-related appointments  
 Research-related concern or complaint 
 Research-related injuries or emergencies 
 Withdrawing from the research study 
 
Principal Investigator: Sean Dowdy, M.D. 
Phone: (507) 266-0225 
 
Study Team Contacts: Karen Ishitani, R.N. 
Phone: (507) 538-5355 
 
Maureen Lemens, R.N. 
Phone: (507) 293-1487 
 
Institution Name and Address: 
Mayo Clinic  
200 First Street SW 
Rochester, MN 55905 
 Rights of a research participant 
 
Mayo Clinic Institutional Review Board (IRB)  
Phone: (507) 266-4000 
Toll-Free: (866) 273-4681  
 Rights of a research participant 
 Any research-related concern or complaint 
 Use of your Protected Health Information 
 Stopping your authorization to use your 
Protected Health Information 
 Withdrawing from the research study 
Research Participant Advocate (RPA) 
(The RPA is independent of the Study Team) 
Phone: (507) 266-9372 
Toll-Free: (866) 273-4681 
 
E-mail: researchparticipantadvocate@mayo.edu 
 Billing or insurance related to this research 
study 
Patient Account Services 
Toll-Free: (844) 217-9591 
 
Other Information:  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
 
 


 
 
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Why are you being asked to take part in this research study? 
 
 
You are being asked to participate in this research study because you are between ages 18 – 80 
and you are scheduled to undergo an open abdominal surgery (laparotomy) for a suspected or 
diagnosed gynecological cancer.   
 
The plan is to have about 104 women take part in this study at Mayo Clinic. 
 
 
Why is this research study being done? 
 
 
The purpose of this research is to gather information about the effectiveness of using two types 
of approved pain medication with the intent to provide improved pain control during the first 
postop day. Both medications are given during the surgical procedure. Liposomal bupivacaine is 
routinely infiltrated into the skin surrounding the abdominal incision and is effective in providing 
good relief of incisional pain. Intrathecal (spinal) hydromorphone, given as a single injection, 
will be used in this study as an additional medication with the intent to provide better 
management of deep abdominal pain during the first 24 hours postop. 
 
 
Information you should know 
 
 
Who is Funding the Study? 
 
Mayo Clinic is providing funding for this study. 
 
 
How long will you be in this research study? 
 
 
You will be in this study until approximately 24 hours after your surgery. Your medical record 
will be reviewed later by the study team for information about your surgery and hospital stay. 
 
 
 


 
 
Approval Date:  
December 2, 2022 
Not to be used after: December 1, 2023 
 
 
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Name and Clinic Number 
 
What will happen to you while you are in this research study? 
 
 
If you agree to participate in this study: 
• You will be asked to complete a short questionnaire in the clinic before surgery. 
• You will be asked about basic health and medical history. 
• You will be randomized to one of two study groups (like the flip of a coin) 
o One group will be assigned to receive only the standard infiltration of medication 
in the abdominal incision at the end of the surgical procedure 
o The other group will be assigned to receive a single intrathecal (spinal) injection 
of pain medication in addition to the standard infiltration of medication in the 
abdominal incision at the end of the surgical procedure. 
• Your surgical procedure will be performed as planned. 
• Your postop care will be standard normal routine.  
• Pain medications will be given as needed per the standard normal routine.   
• Approximately 24 hours after your surgery, you will be asked to complete two short 
questionnaires 
 
 
What are the possible risks or discomforts from being in this research study? 
 
 
Your surgeon will discuss the risks of your scheduled surgery and any tests or procedures that 
are part of your standard clinical care. 
 
The anesthesia staff will discuss the risks related to anesthesia and the risks related to intrathecal 
(spinal) injections if you are assigned to that group. 
 
Possible risks related to spinal injection include puncture site bleeding, infection, hematoma, and 
spinal headache. Possible effects of systemic opioids include itching, nausea and vomiting, 
sedation, and respiratory depression. There is also a possible risk for delayed recovery. As with 
any medication, allergic reactions are possible. 
 
If you think you might be pregnant, you must tell the study team immediately. You cannot be 
enrolled in this study if you are known to be pregnant. 
 
With all research, there is a chance that confidentiality could be compromised; however, we take 
precautions to minimize this risk. 


 
 
Approval Date:  
December 2, 2022 
Not to be used after: December 1, 2023 
 
 
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Are there reasons you might leave this research study early? 
 
 
You may decide to stop at any time. You should tell the study team if you decide to stop and you 
will be advised whether any additional tests may need to be done for your safety.  
 
In addition, the Principal Investigator or Mayo Clinic may stop you from taking part in this study 
at any time: 
o if it is in your best interest,  
o if you do not follow the study procedures,  
o if the study is stopped.  
 
If you leave this research study early, or are withdrawn from the study, no more information 
about you will be collected; however, information already collected about you in the study may 
continue to be used. We will tell you about any new information that may affect your willingness 
to stay in the research study. 
 
 
What if you are injured from your participation in this research study? 
 
 
Where to get help: 
 
If you think you have suffered a research-related injury, you should promptly notify the Principal 
Investigator listed in the Contact Information at the beginning of this form. Mayo Clinic will 
offer care for research-related injuries, including first aid, emergency treatment and follow-up 
care as needed. 
 
Who will pay for the treatment of research related injuries? 
 
Care for such research-related injuries will be billed in the ordinary manner, to you or your 
insurance.  You will be responsible for all treatment costs not covered by your insurance, 
including deductibles, co-payments and coinsurance. 
 
 


 
 
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What are the possible benefits from being in this research study? 
 
 
This study may not make your health better.  However, it is possible that you may have 
improved pain relief after surgery.  Others undergoing similar abdominal surgery may benefit in 
the future from what we learn in this research study. 
 
 
What alternative do you have if you choose not to participate in this  
research study? 
 
 
You do not need to be in this study to receive treatment for your condition. Your other choices 
may include undergoing surgery without participating in the study.  
 
 
What tests or procedures will you need to pay for if you take part in this  
research study? 
 
 
There will not be additional charges to you for participating in this study. However, you and/or 
your insurance will need to pay for your surgery, anesthesia, hospital stay, all other tests and 
procedures that you will have as part of your clinical care, including co-payments and 
deductibles. 
 
If you have billing or insurance questions call Patient Account Services at the telephone 
number provided in the Contact Information section of this form. 
 
 
Will you be paid for taking part in this research study? 
 
 
You will not be paid for taking part in this study. 
 
 


 
 
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Will your information or samples be used for future research? 
 
Your information collected for this study will not be used or shared for future research studies 
even if the identifiable information such as your name, Mayo Clinic number or date of birth is 
removed. 
 
How will your privacy and the confidentiality of your records be protected? 
 
 
Mayo Clinic is committed to protecting the confidentiality of information obtained about you in 
connection with this research study. A unique study ID code will be assigned to you for this 
study. Your data including your questionnaires will be labeled with this code to protect your 
identity and maintain confidentiality. Data collected on paper will be kept in a locked research 
office. Data will be entered into a secure password-protected electronic database with access 
limited to the study team. 
 
During this research, information about your health will be collected.  Under Federal law called 
the Privacy Rule, health information is private.  However, there are exceptions to this rule, and 
you should know who may be able to see, use and share your health information for research and 
why they may need to do so.  Information about you and your health cannot be used in this 
research study without your written permission.  If you sign this form, it will provide that 
permission (or “authorization”) to Mayo Clinic. 
 
Your health information may be collected from: 
• Past, present and future medical records. 
• Research procedures, including research office visits, tests, interviews and 
questionnaires. 
 
Your health information will be used and/or given to others to: 
• Do the research. 
• Report the results. 
• See if the research was conducted following the approved study plan, and applicable rules 
and regulations. 
 


 
 
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Your health information may be used and shared with: 
• Mayo Clinic research staff involved in this study.  
• The sponsor of this study and the people or groups hired by the sponsor to help perform 
this research. 
• The Mayo Clinic Institutional Review Board that oversees the research.  
• Federal and State agencies (such as the Food and Drug Administration, the Department of 
Health and Human Services, the National Institutes of Health and other United States 
agencies) or government agencies in other countries that oversee or review research. 
• A group that oversees the data (study information) and safety of this research.   
 
How your information may be shared with others: 
While taking part in this study, you will be assigned a code that is unique to you, but does not 
include information that directly identifies you. This code will be used if your study information 
is sent outside of Mayo Clinic. The groups or individuals who receive your coded information 
will use it only for the purposes described in this consent form. 
 
If the results of this study are made public (for example, through scientific meetings, reports or 
media), information that identifies you will not be used. 
 
In addition, individuals involved in study oversight and not employed by Mayo Clinic may be 
allowed to review your health information included in past, present, and future medical and/or 
research records. This review may be done on-site at Mayo Clinic or remotely (from an off-site 
location). These records contain information that directly identifies you. However, the 
individuals will not be allowed to record, print, or copy (using paper, digital, photographic or 
other methods), or remove your identifying information from Mayo Clinic. 
 
Is your health information protected after it has been shared with others? 
Mayo Clinic asks anyone who receives your health information from us to protect your privacy; 
however, once your information is shared outside Mayo Clinic, we cannot promise that it will 
remain private and it may no longer be protected by the Privacy Rule. 
 
 
Your Rights and Permissions 
 
 
Participation in this study is completely voluntary. You have the right not to participate at all.  
Even if you decide to be part of the study now, you may change your mind and stop at any time.  
You do not have to sign this form, but if you do not, you cannot take part in this research study. 
 


 
 
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Deciding not to participate or choosing to leave the study will not result in any penalty.  Saying 
‘no’ will not harm your relationship with your own doctors or with Mayo Clinic. 
 
If you cancel your permission for Mayo Clinic to use or share your health information, your 
participation in this study will end and no more information about you will be collected; 
however, information already collected about you in the study may continue to be used. 
 
You can cancel your permission for Mayo Clinic to use or share your health information at any 
time by sending a letter to the address below: 
 
Mayo Clinic 
Office for Human Research Protection 
ATTN:  Notice of Revocation of Authorization 
201 Building 4-60 
200 1st Street SW 
Rochester, MN  55905 
 
Alternatively, you may cancel your permission by emailing the Mayo Clinic Research 
Participant Advocate at: researchparticipantadvocate@mayo.edu. 
 
Please be sure to include in your letter or email: 
• The name of the Principal Investigator, 
• The study IRB number and /or study name, and 
• Your contact information. 
 
Your permission for Mayo Clinic to use and share your health information lasts until the end of 
this study, unless you cancel it.  The study does not end until all data has been collected, checked 
(or audited), analyzed, and reported. Because research is an ongoing process, we cannot give you 
an exact date when the study will end. Sometimes this can be years after your study visits and/or 
activities have ended. 
 
 
 


 
 
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Enrollment and Permission Signatures 
 
 
Your signature documents your permission to take part in this research.  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm)  
 
 
 
 
 
 
 
 
_______________________________ 
Signature 
 
 
 
Person Obtaining Consent  
• I have explained the research study to the participant. 
• I have answered all questions about this research study to the best of my ability. 
 
 
 
Printed Name  
 
 
Date (mm/dd/yyyy) 
 
 
Time (hh:mm am/pm) 
 
 
_______________________________ 
Signature