Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
Phase: NA
Conditions: Pain, Postoperative, Hysterectomy, Narcotic Use, Cryotherapy Effect
Sponsor: Mayo Clinic

 
 
 
 
 
 
 
 
 
 
Abdominal ice packs for pain control and reduction of narcotic use following 
laparoscopic hysterectomy: a randomized controlled trial. 
 
 
 
 
 
Principal Investigator: Tatnai Burnett, M.D. 
Co-Investigator: Gretchen Glaser, M.D. 
Co-Investigator: Nafisseh Warner, M.D. 
Co-Investigator: Shannon Laughlin-Tommaso 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 1.0 – 09.27.2017 
Version 2.0—11.08-2017 
Version 3.0—02.16.2018 

Abdominal ice packs for pain control and reduction of narcotic use following laparoscopic hysterectomy: a randomized controlled trial.  
Tatnai Burnett, M.D. 
 
 
2 
 
 
Significance 
The Center for Disease Control (CDC) released guidelines in 2016 on narcotic prescribing for chronic pain due to growing 
concern regarding narcotic abuse.1 The guidelines suggest minimizing narcotic use for acute pain as a strategy to decrease the 
conversion to long-term use. With more than 600,000 hysterectomies performed annually in the United States,2 there is a dire 
need for establishing alternative pain therapies after surgery. We aim to determine the effectiveness of abdominal ice pack 
use on decreasing narcotic use postoperatively. Ice pack use on the abdominal wall likely inhibits visceral afferent pain fibers 
via somatic afferent nerve cross-talk.3,4 Importantly, patient-reported narcotic use has not been well documented so we will 
plan to accurately document post-discharge use by residual pill counts.  
 
Innovation 
Our goal is to quantify narcotic use after hospital discharge following hysterectomy, and evaluate the effectiveness of 
abdominal ice packs as low cost adjuncts for pain control. We hope to demonstrate the feasibility and effectiveness of ice 
packs for pain reduction as measured by postoperative narcotic use, patient pain scores, and patient subjective assessment of 
acceptability. Abdominal ice packs have yet to be studied as pain control adjuncts in laparoscopic surgery, thus this approach 
is novel.  
We will assess narcotic use after discharge by collecting unused pills from patients. This is an innovative approach to 
document post-discharge narcotic use after laparoscopic hysterectomy, for which there is an absence of published data. Data 
on narcotic use after hysterectomy may become a basis for future recommendations on appropriate narcotic prescribing 
following hysterectomy. Demonstrating a clinically significant narcotic use reduction or pain reduction with abdominal ice 
pack therapy would likely lead to widespread adoption of the practice within gynecology.  
 
Investigators 
Tatnai Burnett, PI; Instructor, obstetrics & gynecology. MIGS surgeon with laparoscopic hysterectomy practice. 
Gretchen Glaser, Co-I: Gynecologic oncologist with robotic hysterectomy practice. 
Shannon Laughlin-Tommaso, mentor: epidemiology and research experience  
 
ABSTRACT  
Background  
Hysterectomy is one of the most common procedures performed on women in the United States, with approximately 600,000 
performed annually.2 The Center for Disease Control (CDC) released guidelines in 2016 on narcotic prescribing for chronic 
pain due to growing concern regarding narcotic abuse.1 The guidelines suggest parameters for narcotic prescribing for acute 
pain due to its relationship to long-term narcotic use, with a focus on limiting the amount of narcotics prescribed. This is 
based on evidence suggesting a direct relationship between use of postoperative narcotics in opioid naïve patients and 
increased risk of continued use in 1 year.1 In light of the CDC guidelines, alternative means to reduce patient pain and 
narcotic use after hysterectomy are clinically relevant. In addition, documenting narcotic use patterns after hospital discharge 
following hysterectomy is vital to understand appropriate prescribing practices.  
 
The use of postoperative cooling for pain has previously been shown to be effective in a variety of procedures, including 
laparotomy,5 inguinal hernia repair,6 total knee arthroplasty,7 craniotomy,8 oral surgery,9 and tonsillectomy,10 but has yet to 
be described for laparoscopic surgery.  Safety in regards to surgical site infection (SSI) is evidenced by the routine use of 
postoperative ice packs in orthopedic surgery based on a robust literature demonstrating no increased rate of SSIs in total-
knee arthroplasty with hardware placement or anterior cruciate ligament repair procedures.7,11 Abdominal ice packs placed 
continuously for 24 hours after laparotomy in one study resulted in both decreased pain scores and reduced use of narcotics 
during the 24 hour time period, with no incidence of hypothermia.5  
 
The primary investigator routinely uses abdominal ice packs following laparoscopic hysterectomy and has observed 
beneficial effects on pain reduction. In contrast to laparotomy where the wound is a significant pain generator and direct 
application of ice is intuitive, in laparoscopic surgery much of the pain-generating tissue trauma is intraperitoneal and pelvic 
in nature, away from the abdominal wall. A plausible mechanism for pain inhibition with abdominal placement of ice packs 
in this scenario may be found in abdominopelvic neuroanatomy. Cross-talk between neuro pathways has been used to 
describe referred pain to the abdominal wall via somatic nerve distributions despite originating from visceral afferents.3 Pain 
from visceral afferent nerves traveling through the dorsal horn of the spinal cord come in close association with poorly 
myelinated somatic afferents, causing cross-talk to occur and referred pain in the corresponding dermatome.4 This viscero-
somatic convergence is reported between the ovaries/distal fallopian tubes and the iliohypogastric nerve, the proximal 
fallopian tubes/uterine fundus and the ilioinguinal/genitofemoral nerves, and the uterine fundus/lower uterine segment and 

Abdominal ice packs for pain control and reduction of narcotic use following laparoscopic hysterectomy: a randomized controlled trial.  
Tatnai Burnett, M.D. 
 
 
3 
 
the lateral femoral cutaneous nerve. The reverse pathway, pain from the somatic afferents referring to the pelvic visceral 
afferents, has also been described.4 Accordingly, applying ice to the abdominal wall and its somatic afferents may indeed 
have the ability to interfere in some fashion with pain signals originating from the pelvic visceral afferents and improve 
laparoscopic pain control despite the lack of a significant abdominal wound. 
 
 
Hypothesis  
The use of abdominal ice packs following laparoscopic hysterectomy will result in improved pain control and reduction in 
narcotic consumption compared to patients not using ice packs.  
 
Specific Aims  
1. Document average patient morphine metabolic equivalents (MME) consumption after laparoscopic hysterectomy from 
hospital discharge to narcotic self-discontinuation. 
2. Evaluate the effect of abdominal ice packs vs routine care on total (MMEs) consumed by patients during the 
perioperative and entire postoperative period. 
3. Evaluate the effect of abdominal ice packs vs routine care on validated pain measures during the first 12 hours after 
surgery. 
 
Is the Research aiming to answer to an unmet need of the patient (either a specific clinical need or patient 
satisfaction)? If yes, please explain in detail. 
Yes. Reducing postoperative pain and reducing postoperative narcotic use are unmet needs of the patient.  Current postop 
pain regimens for laparoscopic surgery depend heavily on narcotic and non-narcotic medications, thus there is a need for low-
cost non-medication alternatives. Furthermore, reducing narcotic use postoperatively may also reduce the risk of future 
narcotic dependence, which lies at the core of this unmet need.  
 
Research Plan and Methods  
Patients ≥ 18 years old undergoing laparoscopic (either conventional or robotic) hysterectomy will be recruited. Patients will 
be excluded for (a) taking opioid analgesics, including Tramadol, on a daily basis within the two weeks prior to surgery (b) 
planned ICU admission identified prior to randomization, (c) conversion to laparotomy or any incision ≥4 cm, (d) regional 
anesthesia or tap block use, and (e)  planned same-day discharge. The intent of excluding patients who are opioid tolerant, 
defined as patients who are chronically receiving opioid analgesics on a daily basis, is to prevent confounding of our specific 
aims related to total opioid use.12 Patients will not be excluded due to additional surgical procedures performed or due to 
malignancy as an indication for surgery. Trial will adhere to CONSORT guidelines.13 
 
In the preoperative area, the Brief Pain Inventory-short form (BPI)14,15 will be administered by study personnel, as the first of 
two questionnaires.  The BPI short form is a validated measure that will allow for quick assessment of baseline and post-
operative pain severity and impact on function. Preoperative and intraoperative medications will be standardized using a 
modified Magic Pathway (multimodal analgesia) with intraoperative narcotic guidelines. All intraoperative and postoperative 
pain management decisions will be left to the discretion of the subject’s surgeon. Following incision closure, the surgeon will 
determine eligibility for randomization. Subjects will be randomized, using REDcap, by a study coordinator to abdominal ice 
pack plus routine care or routine Randomization will be stratified into two groups, patients with chronic pelvic pain (pain 
present for ≥ 6 months, excluding isolated dysmenorrhea) and patients without chronic pelvic pain; there will be no 
stratification for surgical approach. Blinding will not be possible for patients, physicians, or study coordinator.  
 
A large zip lock bag (size standardized) full of ice chips, placed inside a pillow case, will be placed directly on the abdomen 
prior to leaving the operating room, for subjects randomized to ice therapy. Ice will be kept on the abdomen continuously for 
the first 12 hours, however patients will be allowed to remove and replace ice as desired for comfort. Bag will be refilled with 
ice by hospital staff as needed, and patient will carry the bag home for continued use after discharge. Patient will be 
encouraged to continue using ice pack through 24 hours and beyond if found to be helpful. 
 
Safety will be carefully monitored in ice pack subjects. Ice packs will always be placed on the abdomen wrapped within a 
pillow case to reduce the risk of cold burns from ice being directly on the skin. Subjects may remove the ice at any time if 
discomfort is experienced, limiting the risk of frost bite. Unit nurse will check skin at minimum every 4 hours, and evaluate 
per the current Nursing Procedural Guideline: Ice Pack Use (immediate removal if skin appears mottled, gray, macerated, 
blistered, and/or if patient reports extreme burning or numbness). Any skin changes at subject discharge will be recorded as 
adverse events and prompt a protocol safety review if determined to be secondary to ice pack use (as opposed to skin prep, 

Abdominal ice packs for pain control and reduction of narcotic use following laparoscopic hysterectomy: a randomized controlled trial.  
Tatnai Burnett, M.D. 
 
 
4 
 
bandages, etc.). Safety of a continuous use protocol has previously been demonstrated by Watkins et al, where continuous ice 
packs were used against an abdominal incision for 24 hours in 27 patients with zero patients experiencing thermal injury. 
Anecdotally, the primary investigator has be using continuous ice packs as described in this protocol for all laparoscopic 
hysterectomy patients since mid -2016; conservatively, over 90 patients during that time have used ice packs, with zero 
thermal injuries noted (the primary investigator personally sees and examines all of his patients on postoperative day 1, after 
12-24 hours of ice pack use). 
 
Demographics (i.e., age, gravida, para, BMI) and intraoperative statistics will be documented (surgical time, blood loss, 
uterine weight, additional procedures, intraoperative complications, use of pre- and/or post-incision local analgesia). During 
postoperative admission, arrival time to PACU, lowest recorded temperature, pain scores (arrival to PACU, last pain score in 
PACU, and all inpatient pain scores through 12 hours), and immediate complications will be recorded. Inpatient pain scores 
will be abstracted from the medical record nurse charting, which per protocol are at minimum every 4 hours.  
After between 12 and 24 hours or at hospital discharge (whichever occurs first), subjects will be administered a second 
survey, reflecting a compilation of the following tools. The ice group will be asked to complete the BPI short form, the 
Overall Benefit of Analgesia Score (OBAS)16 measure, and answer questions  assessing ice pack tolerability, satisfaction 
with pain control, and perceived adherence to use (% of time ice pack perceived to be on abdomen during first 12 h). Routine 
care patients will only complete the BPI short form and OBAS. The OBAS is a 7-item, validated tool specifically designed 
for post-operative assessment of pain, side effects and satisfaction with analgesia within the first 24 hours following 
surgery17.   
 
MMEs will be recorded in split timeframes: starting from subject arrival at PACU to discharge from PACU; arrival to floor 
until 12 hours s/p surgery; 12 hours s/p surgery until hospital discharge; and from hospital discharge to self-discontinuation. 
Hospital charts will be used to obtain MMEs while subjects are admitted. Subjects will be instructed to keep unused narcotic 
medication and bring it with them for accurate use counts at the scheduled post-operative visit, typically six weeks following 
dismissal. A medication/pain diary will be kept by patients after discharge to include pain scores and all narcotic-type 
medications consumed, including those not prescribed for the current surgery. The diary will be kept daily until the last dose 
of narcotic pain medication is needed. Subjects in the treatment arm will additionally record duration of ice pack use during 
the first 24 hours after hospital discharge. This measure will be incorporated into the diary for ease of completion. 
 
At the scheduled postoperative visit, pill counts will be completed, medication/pain diary collected, and 30-day postoperative 
complications (surgical site infections, readmissions, etc.) assessed. If patients do not return to Mayo Clinic for a postop  
exam, a prepaid envelope will be sent to have diary returned by mail and complications/readmissions and pill count assessed 
by phone with the study coordinator. 
 
Statistics  
Descriptive statistics will be applied to demographics, intraoperative, and postoperative data. Comparisons between groups 
will be performed using a 2-tailed t-test or Mann-Whitney U for parametric and non-parametric data as appropriate. A p-
value of 0.05 will be used to determine statistical significance. 
 
Primary analysis will be an intention-to-treat analysis of total MME use after surgery. Secondary analyses will evaluate effect 
on pain scores, patient satisfaction with pain control,  
 
No previously published data on narcotic consumption after discharge for any minimally invasive hysterectomy (vaginal, 
laparoscopic, robotic) could be identified in a literature search. Chart review averaging 3 patients’ data demonstrated average 
use of 150 MMEs after laparoscopic hysterectomy from PACU admission to hospital discharge. Assuming use of 20 
oxycodone 5 mg tablets following discharge yields an additional 150 MMEs; total estimated use after laparoscopic 
hysterectomy is 300 MMEs. Considering a 20% MME reduction as clinically significant (8 x 5mg oxycodone pills), an alpha 
of 0.05, power of 90%, and SD of 100 MMEs with a 1:1 sampling ratio, 59 subjects per arm (total 118) would be required to 
demonstrate a statistically significant difference. Addition of a 20% margin for losses to follow up, pre- and post-
randomization exclusions, 142 patients would be targeted for recruitment. 
 
Impact 
Publication is expected in a high impact factor journal given study design and potential for patient benefit. Results are 
directly relevant to current Mayo Clinic clinical practice and could immediately be applied to patient care. Additional 
research on narcotic use and/or ice pack therapy in other gynecologic surgeries could follow, as well as evaluation in specific 
patient populations such as chronic pelvic pain. This could allow development of an area of clinical expertise for personal 

Abdominal ice packs for pain control and reduction of narcotic use following laparoscopic hysterectomy: a randomized controlled trial.  
Tatnai Burnett, M.D. 
 
 
5 
 
career development. Data from this study, if positive, could tie in to the current enhanced recovery (ERAS) program adding 
to the current armamentarium. Further evaluation into other laparoscopic procedures may also be considered; grants from 
organizations such as AAGL and ACOG could be sought to support this expansion. If a difference is noted, then more 
sophisticated ice packs or cooling systems could be an interest to Mayo Clinic Ventures and an application for device 
creation could be submitted at next available RFA.  
 
 
Timeline  
In 2016, 586 laparoscopic or robotic hysterectomies were performed at Mayo Clinic Rochester. Rate of preoperative narcotic 
use in this population is unknown, but 20% estimate would be generous. This would leave about 470 patients for recruitment, 
and assuming an enrollment of 50% we are left with 235 subjects in a year. As such, 12 months or less for subject 
recruitment, should be sufficient; 6 months are estimated for protocol development and IRB approval, and another 6 months 
for data analysis, manuscript preparation, and publication. Total projected time from project initiation to publication would 2 
years.  
 
 
References 
 
1. 
Dowell D, Haegerich T, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — 
United States, 2016. MMWR Recomm Rep. 2016;65(No. RR-1):1-49. 
2. 
Doll K, Dusetzina S, Robinson W. Trends in Inpatient and Outpatient Hysterectomy and 
Oophorectomy Rates Among Commercially Insured Women in the United States, 2000-2014. 
JAMA Surgery. 2017;151(9):876-877. 
3. 
Shoja MM, Sharma A, Mirzayan N, et al. Neuroanatomy of the female abdominopelvic region: A 
review with application to pelvic pain syndromes. Clin Anat. 2013;26(1):66-76. 
4. 
Perry CP. Peripheral neuropathies causing chronic pelvic pain. J Am Assoc Gynecol Laparosc. 
2000;7(2):281-287. 
5. 
Watkins A, Johnson T, Shrewsberry A, et al. Ice Packs Reduce Postoperative Midline Incision 
Pain and Narcotic Use: A Randomized Controlled Trial. 2014;219(3):511–517. 
6. 
Koc M, Tez M, Yoldas O, Dizen H, Gocmen E. Cooling for the reduction of postoperative pain: 
prospective randomized study. Hernia. 2006;10(2):184-186. 
7. 
Adie S, Naylor JM, Harris IA. Cryotherapy After Total Knee Arthroplasty : A Systematic Review 
and Meta-Analysis of Randomized Controlled Trials. 2010;25(5):709–715. 
8. 
Shin Y, Lim N, Yun S, Park K. A randomised controlled trial of the effects of cryotherapy on 
pain, eyelid oedema and facial ecchymosis after craniotomy. Journal of clinical nursing. 
2009;18(21):3029-3036. 
9. 
Zandi M, Amini P, Keshavarz A. Effectiveness of cold therapy in reducing pain, trismus, and 
oedema after impacted mandibular third molar surgery: a randomized, self-controlled, observer-
blind, split-mouth clinical trial. International journal of oral and maxillofacial surgery. 
2016;45(1):118-123. 
10. 
Sylvester DC, Rafferty A, Bew S, Knight LC. The use of ice-lollies for pain relief post-paediatric 
tonsillectomy. A single-blinded, randomised, controlled trial. Clinical Otolaryngology. 
2011;36(6):566-570. 

Abdominal ice packs for pain control and reduction of narcotic use following laparoscopic hysterectomy: a randomized controlled trial.  
Tatnai Burnett, M.D. 
 
 
6 
 
11. 
Martimbianco AL, Gomes da Silva BN, de Carvalho AP, Silva V, Torloni MR, Peccin MS. 
Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament 
reconstruction. A systematic review of the literature. Phys Ther Sport. 2014;15(4):261-268. 
12. 
Network. NCC. NCCN Guidelines Version 1.2018 Adult Cancer Pain. 2018; 
https://www.nccn.org/professionals/physician_gls/recently_updated.aspx. Accessed February 16, 
2018. 
13. 
Schulz K, Altman D, Moher D. CONSORT 2010 statement: updated guidelines for reporting 
parallel group randomized trials. Obstet Gynecol. 2010;115(5):1063-1070. 
14. 
Atkinson TM, Rosenfeld BD, Sit L, et al. Using confirmatory factor analysis to evaluate construct 
validity of the Brief Pain Inventory (BPI). Journal of pain and symptom management. 
2011;41(3):558-565. 
15. 
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain 
inventory for use in documenting the outcomes of patients with noncancer pain. The Clinical 
journal of pain. 2004;20(5):309-318. 
16. 
Lehmann N, Joshi G, Dirkmann D, et al. Development and longitudinal validation of the overall 
benefit of analgesia score: a simple multi-dimensional quality assessment instrument. British 
journal of anaesthesia. 2010;105(4):511-518. 
17. 
Kushner DM, LaGalbo R, Connor JP, Chappell R, Stewart SL, Hartenbach EM. Use of a 
bupivacaine continuous wound infusion system in gynecologic oncology: a randomized trial. 
Obstetrics & Gynecology. 2005;106(2):227-233. 
 

 
 
Approval Date:  
October 25, 2018 
Not to be used after: October 24, 2019 
 
 
IRB#:  17-007182 00 
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Name and Clinic Number 
 
 
RESEARCH PARTICIPANT CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Study Title: Abdominal ice packs for pain control and reduction of narcotic use following 
laparoscopic hysterectomy: A randomized controlled trial  
 
IRB#:  
17-007182  
 
Principal Investigator: Tatnai Burnett, M.D. and Colleagues 
 
Please read this information carefully. It tells you important things about this research study. A 
member of our research team will talk to you about taking part in this research study.  If you 
have questions at any time, please ask us. 
 
Take your time to decide.  Feel free to discuss the study with your family, friends, and healthcare 
provider before you make your decision.   
 
To help you decide if you want to take part in this study, you should know: 
• Taking part in this study is completely voluntary.  
• You can choose not to participate.  
• You are free to change your mind at any time if you choose to participate.   
• Your decision won’t cause any penalties or loss of benefits to which you’re otherwise 
entitled. 
• Your decision won’t change the access to medical care you get at Mayo Clinic now or in 
the future if you choose not to participate or discontinue your participation.   
 
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. 
 
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 a copy of this form to keep. A copy of this form will be put 
in your medical record. 
 
 
 
 

 
 
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Not to be used after: October 24, 2019 
 
 
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Name and Clinic Number 
 
CONTACT INFORMATION 
 
 
You can contact … 
At … 
If you have questions about … 
Principal 
Investigator(s): 
Dr. Tatnai Burnett 
 
Study Team Contact: 
Marnie Wetzstein, RN 
 
 
 
Phone: 
(507) 538-5783 
 
Phone: 
(507) 266-4813 
 
Institution Name and Address: 
Mayo Clinic 
200 First Street Southwest 
Rochester, MN 55905 
 Study tests and procedures 
 Research-related injuries or 
emergencies 
 Any research-related concerns or 
complaints 
 Withdrawing from the research study 
 Materials you receive 
 Research-related appointments 
Mayo Clinic 
Institutional Review 
Board (IRB) 
Phone: 
(507) 266-4000 
 
Toll-Free: 
(866) 273-4681 
 
 Rights of a research participant 
 
Research Subject 
Advocate 
(The RSA is independent 
of the Study Team) 
Phone: 
(507) 266-9372 
 
Toll-Free: 
(866) 273-4681 
 
E-mail: 
researchsubjectadvocate@mayo.edu 
 
 Rights of a research participant 
 Any research-related concerns or 
complaints 
 Use of your Protected Health 
Information 
 Stopping your authorization to use 
your Protected Health Information 
Research Billing 
 
Rochester, MN: (507) 266-5670 
 Billing or insurance related to this 
research study 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law, and http://www.mayoclinic.org. These web sites will not include information that 
can identify you. At most, the web sites will include a summary of the results. You can search 
this web site at any time.  

 
 
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1. 
Why are you being asked to take part in this research study? 
 
 
You are being asked to take part in this research study because you are scheduled to undergo a 
laparoscopic (conventional laparoscopic or robotic laparoscopic) hysterectomy, a surgical 
procedure to remove the uterus. 
 
The plan is to have about 142 people take part in this study at Mayo Clinic. 
 
 
2. 
Why is this research study being done? 
 
 
The purpose of this study is to evaluate the effect of using ice packs on the abdomen 
immediately after laparoscopic hysterectomy surgery on pain control.  
 
 
3. 
Information you should know 
 
 
Who is Funding the Study? 
 
Mayo Clinic is funding this study. 
 
 
4. 
How long will you be in this research study? 
 
 
You will be in this study from the time of your surgery until your post-operative examination, 
which occurs approximately six to eight weeks after surgery. 
 
 
5. 
What will happen to you while you are in this research study? 
 
 
If you are eligible for the study, you will be asked to participate in the following: 
 

 
 
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We will assign you by chance (like a coin toss) to the routine pain control group or the ice and 
routine pain control group. You and the Principal Investigator can’t choose your study group. 
You will have an equal chance of being assigned to either group. 
 
Routine pain control group - You will receive the pain medication routinely provided 
after surgery.  
 
Ice and routine pain control group  - You will use an ice pack on your abdomen 
continuously for the first 12 hours after surgery and receive pain medicine, as routinely 
provided after surgery. The ice may be removed during the first 12 hours, as needed, for 
comfort. Ice may continue to be used after 12 hours, if desired for your comfort.  
 
You will be asked to complete a pain questionnaire just before surgery, which will take 
approximately two minutes to complete. You will be asked to complete a second pain 
questionnaire between 12 and 24 hours after surgery, before you are dismissed home. This 
questionnaire will take approximately five minutes to complete.  
 
You will be provided a simple diary to record your daily pain scores, use of narcotic pain 
medicine, and if in the ice group, use of ice for post-operative pain control, after discharge from 
the hospital. We will ask you to record your responses in the diary daily until you are no longer 
requiring narcotic pain medication and, if in the ice group, are no longer using ice packs. When 
you return to the clinic approximately 6-8 weeks after surgery, the study team will review your 
home diary and ask you to count how many narcotic pain pills you have remaining from the 
prescription provided in the hospital. If you are seeing a provider closer to home for a post-
operative visit, a study team member will call you to review the diary and ask you to count the 
remaining narcotic pain pills. 
 
We will also collect information about your health from you and your medical record up to 
approximately six-eight weeks after surgery.  
 
 
6. 
What are the possible risks or discomforts from being in this  
research study? 
 
 
Ice can cause burns when applied directly to the skin or for extended periods of time. To 
minimize this risk, we will apply the ice pack in a cloth cover to protect your skin. You may 
remove the ice at any time for discomfort. Further, the nursing staff will monitor your skin 
during the time the ice packs are used in the hospital. 
 

 
 
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Name and Clinic Number 
As with all research, there is a chance that confidentiality could be compromised; however, we 
take precautions to minimize this risk. 
 
 
7. 
Are there reasons you might leave this research study early? 
 
 
You may decide to stop at any time.  You should tell the Principal Investigator 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: 
• if it is in your best interest,  
• if you don’t follow the study procedures,  
• 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. 
 
 
8. 
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. 
 

 
 
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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. 
 
 
9. 
What are the possible benefits from being in this research study? 
 
 
This study may not make your health better.  However, other women undergoing laparoscopic 
hysterectomy may benefit in the future from what we learn in this research study. 
 
 
10. 
What alternative do you have if you choose not to participate 
in this research study? 
 
 
You don’t have to be in this study to receive treatment for your condition. You can undergo a 
laparoscopic hysterectomy and receive the routine pain management.  
 
 
11. 
What tests or procedures will you need to pay for if you take part  
in this research study?  
 
 
You won’t need to pay for tests and procedures which are done just for this research study.  
These tests and procedures are: 
• Pain questionnaires and diary 
• Ice packs 
 
However, you and/or your insurance will need to pay for all other tests and procedures that you 
would have as part of your clinical care, including co-payments and deductibles. 
 
 
12. 
Will you be paid for taking part in this research study? 
 
 
You won’t be paid for taking part in this study. 
 

 
 
Approval Date:  
October 25, 2018 
Not to be used after: October 24, 2019 
 
 
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Name and Clinic Number 
 
 
13. 
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. The data collected for this study will be stored and evaluated 
on password protected computers on the Mayo Clinic campus. This data will only be accessible 
to study personnel. 
 
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.   
 
Health information may be collected about you from: 
• Past, present and future medical records. 
• Research procedures, including research office visits, tests, interviews and 
questionnaires. 
 
Why will this information be used and/or given to others? 
• To do the research. 
• To report the results. 
• To see if the research was done correctly. 
 
If the results of this study are made public, information that identifies you will not be used. 
 
Who may use or share your health information? 
• Mayo Clinic research staff involved in this study.  
 
With whom may your health information be shared?  
• The Mayo Clinic Institutional Review Board that oversees the research.  
• Researchers involved in this study at other institutions. 
• 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. 
 

 
 
Approval Date:  
October 25, 2018 
Not to be used after: October 24, 2019 
 
 
IRB#:  17-007182 00 
Page 8 of 9 
IRB Doc. Ctrl # 10013.29 
 
 
 
 
 
 
 
Name and Clinic Number 
• The sponsor(s) of this study and the people or groups it hires to help perform this 
research. 
• A group that oversees the data (study information) and safety of this research. 
 
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 Privacy Rights 
You do not have to sign this form, but if you do not, you cannot take part in this research study. 
 
If you cancel your permission 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. 
 
If you choose not to take part or if you withdraw from this study, it will not harm your 
relationship with your own doctors or with Mayo Clinic. 
 
You can cancel your permission 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 
200 1st Street SW 
Rochester, MN  55905 
 
Alternatively, you may cancel your permission by emailing the Mayo Clinic Research Subject 
Advocate at: researchsubjectadvocate@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 lasts until the end of this study, unless you cancel it.  Because research is an 
ongoing process, we cannot give you an exact date when the study will end. 
 
 
 

 
 
Approval Date:  
October 25, 2018 
Not to be used after: October 24, 2019 
 
 
IRB#:  17-007182 00 
Page 9 of 9 
IRB Doc. Ctrl # 10013.29 
 
 
 
 
 
 
 
Name and Clinic Number 
 
 
 
 
ENROLLMENT AND PERMISSION SIGNATURES 
 
 
Your signature documents your permission to take part in this research.  
 
 
 
  
 
 
 
          
 
 
   : 
       AM/PM   
Printed Name  
 
 
 
Date 
 
 
 
Time   
 
 
 
 
_______________________________ 
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. 
 
 
 
  
 
 
 
          
 
 
   : 
       AM/PM   
Printed Name  
 
 
 
Date 
 
 
 
Time           
 
 
_______________________________ 
Signature