Effect of Cold Therapy Implementation on Multi-modal Postoperative Pain Management in Women Undergoing Laparoscopic Hysterectomy
Phase: NA
Conditions: Pain, Postoperative
Sponsor: Cleveland Clinic Florida

 
 
 
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WOMEN’S HEALTH INSTITUTE 
DEPARTMENT OF GYNECOLOGY 
CLEVELAND CLINIC FLORIDA 
 
 
 
EFFECT OF COLD THERAPY IMPLEMENTATION ON MULTI-MODAL POSTOPERATIVE 
PAIN MANAGEMENT IN WOMEN UNDERGOING LAPAROSCOPIC HYSTERECTOMY: A 
PILOT STUDY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INVESTIGATOR’S SIGNATURE PAGE  
 
 
Protocol Number or Version: 
__________3____________ 
 
Protocol Date: 
 
 
________12/27/2016______ 
 
 
EFFECT OF COLD THERAPY IMPLEMENTATION ON MULTI-MODAL POSTOPERATIVE 
PAIN MANAGEMENT IN WOMEN UNDERGOING LAPAROSCOPIC HYSTERECTOMY: A 
RANDOMIZED CONTROL TRIAL 
 
The signature below constitutes the approval of this protocol and the attachments, and provides the 
necessary assurances that this trial will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines. 
 
Investigator: 
 
Signed: 
Pamela Frazzini Padilla, M.D., MIGS Fellow 
Date: 
12/27/2016 
 
Michael L. Sprague, M.D. 
Date: 
12/27/2016 
 
Name 
Title 
 
 
 
 

 
 
 
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[PAGE TO BE PRINTED AND SIGNED WITH EACH FINAL PROTOCOL VERSION] 
 
 
Name and Address of Institution:  ___Cleveland Clinic Florida_________________ 
 
 
 
 
            ___Department of Gynecology_______________ 
 
 
 
 
            ___2950 Cleveland Clinic Blvd______________ 
 
 
 
 
            ___Weston, FL 33331______________________ 
 
 
 
 
 
 
 
 
 
ABBREVIATIONS 
In order of appearance 
 
MIGS   Minimally Invasive Gynecologic Surgery 
ERAS   Enhanced Recovery After Surgery 
POD    Postoperative Day 
NRS     Numeric Rating Scale 
ASIS    Abdominal Surgery Impact Scale 
PACU Post-anesthesia Care Unit 
EHR    Electronic Health Record 
SRS    Surgical Recovery Scale 
PSIL   Pain Score and Intervention Log 
IRB    Institutional Review Board 
CCF   Cleveland Clinic Florida 
CRF   Case Report Form 
 
 
 
 
 

 
 
 
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TABLE OF CONTENTS 
Title Page .....................................................................................................................................  
Abbreviations ...............................................................................................................................  
Table of Contents .........................................................................................................................  
Research Schema ..........................................................................................................................  
1.0 Introduction ............................................................................................................................  
1.1 Background ................................................................................................................  
1.2 Investigational Agent (if applicable) ...........................................................................  
1.3 Preclinical Data (if applicable) ....................................................................................  
1.4 Clinical Data to Date (if applicable) ............................................................................  
1.5 Dose Rationale and Risk/Benefits (if applicable) ........................................................  
2.0 Study Objectives .....................................................................................................................  
3.0 Study Design ..........................................................................................................................  
3.1 General Design ...........................................................................................................  

 
 
 
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3.2 Primary Study Endpoints ............................................................................................  
3.3 Secondary Study Endpoints ........................................................................................  
3.4 Primary Safety Endpoints ...........................................................................................  
4.0 Subject Selection and Withdrawal ...........................................................................................  
     4.1 Inclusion Criteria ...............................................................................................................  
     4.2 Exclusion Criteria ..............................................................................................................  
     4.3 Subject Recruitment and Screening ....................................................................................  
     4.4 Early Withdrawal of Subjects .............................................................................................  
          4.4.1 When and How to Withdraw Subjects .........................................................................  
          4.4.2 Data Collection and Follow-up for Withdrawn Subjects ..............................................  
5.0 Study Drug (or Device) ...........................................................................................................  
5.1 Description .................................................................................................................  
5.2 Treatment Regimen ....................................................................................................  
5.3 Method for Assigning Subjects to Treatment Groups ..................................................  
5.4 Preparation and Administration of Study Drug (or Device) .........................................  
5.5 Subject Compliance Monitoring .................................................................................  
5.6 Prior and Concomitant Therapy ..................................................................................  
5.7 Packaging ...................................................................................................................  
5.8 Blinding of Study Drug (or Device) ............................................................................  
5.9 Receiving, Storage, Dispensing and Return .................................................................  
5.9.1 Receipt of Drug (or Device) Supplies ..........................................................  
5.9.2 Storage........................................................................................................  
5.9.3 Dispensing of Study Drug (or Device) .........................................................  
5.9.4 Return or Destruction of Study Drug (or Device) .........................................  
6.0 Study Procedures ....................................................................................................................  
6.1 Pre-registration and Screening ....................................................................................   
 
6.2 Visit 1 ........................................................................................................................  
6.2 Visit 2, etc. .................................................................................................................  
6.3 Study Calendar of Procedures .....................................................................................  
7.0 Statistical Plan ........................................................................................................................  
7.1 Sample Size Determination.........................................................................................  
7.2 Statistical Methods .....................................................................................................  
7.3 Subject Population(s) for Analysis ..............................................................................  
8.0 Safety and Adverse Events ......................................................................................................  

 
 
 
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8.1 Definitions: Adverse Event; Serious Adverse Event; Adverse Event Reporting Period; 
Preexisting Condition; General Physical Examination Findings; Post-study Adverse Event; 
Abnormal Laboratory Values; Hospitalization; Prolonged Hospitalization or Surgery .......  
8.2 Recording of Adverse Events .....................................................................................  
8.3 Reporting of Serious Adverse Events ..........................................................................  
8.3.1 Study Sponsor Notification by Investigator .................................................  
8.3.2 IRB Notification by Investigator .................................................................  
8.3.3 FDA Notification by Sponsor ......................................................................  
8.4 Unblinding Procedures ...............................................................................................  
8.5 Stopping Rules ...........................................................................................................  
8.6 Medical Monitoring ....................................................................................................  
8.6.1 Internal Data Safety Monitoring Board (DSMB) .........................................  
8.6.2 Independent Data Safety Monitoring Board (DSMB) ..................................  
9.0 Data Handling and Record Keeping ........................................................................................  
9.1 Confidentiality ........................................................................................................................  
9.2 Source Documents ......................................................................................................  
9.3 Case Report Forms .....................................................................................................  
9.4 Records Retention ......................................................................................................  
10.0 Study Monitoring, Auditing, and Inspecting ..........................................................................  
10.1 Study Monitoring Plan ..............................................................................................  
10.2 Auditing and Inspecting ............................................................................................  
11.0 Ethical Considerations ..........................................................................................................  
12.0 Publication Plan ....................................................................................................................  
13.0 References ............................................................................................................................  
14.0 Attachments ..........................................................................................................................  
 
 
 
 
 
 
 

 
 
 
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RESEARCH SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enrollment and Informed Consent  
Prior to the day of Surgery 
Day of Surgery: Pre-Operatively 
-NRS pain Score 
-ASIS QoL score 
 
Laparoscopic Surgical Procedure 
-Randomization in OR after conclusion of case 
-Initiation of cold therapy in OR, collection of surgical data 
24 Hours Post-operatively 
-NRS pain score 
-Total narcotics used to date 

 
 
 
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1.0 INTRODUCTION 
1.1.  Background 
Pain is an inevitable side effect following a surgical procedure. Post-operative pain arises from 
local tissue trauma and inflammation, which subsequently activate surrounding nociceptive pain 
receptors.1, 2 Providing adequate analgesia to reduce post-operative pain is important for recovery by 
improving outcomes, increasing patient satisfaction and reducing the risk of chronic pain.3, 4 Evidence 
suggests, however, that less than half of patients undergoing surgery report adequate post-operative 
pain relief.5 
The goal of postoperative pain management is to relieve pain while keeping side effects to a 
minimum. Narcotics, although often necessary, are well known for their side effect profile including 
sedation, respiratory depression, nausea, vomiting, pruritus, and inhibition of bowel function. In the 
United States, chronic opioid use and abuse continues to impose a burden of morbidity, and several 
studies suggest that surgery, in and of itself, is a risk factor for chronic opioid use.6 In addition, over 
prescription of narcotics after surgery is common given our lack of knowledge on narcotic 
requirements postoperatively as an outpatient, and therefore retained surplus medication often 
provides a readily available source of non-prescription opioids.7  
Although minimally invasive surgical techniques aim to decrease both the visceral and non-
visceral burden of pain compared to open procedures, patients still generally require narcotic and 
nonnarcotic analgesia following minimally invasive gynecologic surgeries (MIGS). Enhanced 
recovery after surgery (ERAS) pathways in gynecologic/oncology surgery have shown significant 
improvements in recovery time and pain control, as well as decreased narcotic demands. The 
emphasis of post-operative pain management is on multimodal analgesia regimens.8 Currently, most 
ERAS literature for MIGS focuses on multimodal analgesia from a pharmacologic perspective, 
including acetaminophen, NSAIDs, gabapentin and dexamethasone.9 Currently, non-pharmacologic 
methods of analgesia are not well supported in gynecologic laparoscopic surgery, and neither TAP 
72 Hours Post-operatively 
-NRS pain score 
-ASIS QoL score 
-Total narcotics used to date 
10-14 Days Post-operatively 
-Count of Total Narcotic Pills remaining 
-Collection of pain score and intervention log 
-SRS score 
Study Completion 

 
 
 
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blocks nor intraperitoneal instillation of local anesthetic are recommended based on the current level 
of evidence.9  
Non-pharmacologic cold therapy, such as ice packs or cold gel packs, is an effective form of 
postoperative analgesia in sports medicine, orthopedic surgery, hernia repair and maxillofacial 
surgery.2,10,11,12,13 It has even been shown to improve quality of life scores post-operatively in 
maxillofacial surgery.12 Cold therapy is thought to act as a local anesthetic by decreasing 
inflammation, reducing edema, decreasing metabolic demands, slowing nerve conduction velocity 
and reducing muscles spasms.1,11,12,13 It is inexpensive, low risk and easily applicable in an outpatient 
setting, with very few adverse side effects.10 Currently, ERAS literature in gynecology does not 
include the use of cold therapy following gynecologic/oncology surgery. Based on clinical 
experience, however, individual hospital protocols have incorporated cold therapy application into 
post-operative multimodal analgesia regimens. Watkins et al. demonstrated that the application of ice 
packs to vertical midline incisions postoperatively, resulted in significantly decreased post-operative 
pain scores and decreased need for narcotic analgesia.1 To our knowledge, there is no literature 
regarding the use of cold therapy post-operatively in laparoscopic, and more specifically gynecologic, 
surgery.  
This study aims to examine if there is a difference in post-operative pain scores with the 
application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, 
when compared to no cold therapy. Secondarily, we will examine post-operative quality of life scores, 
postoperative surgical recovery scores, as well as narcotic use among the two groups. We also aim to 
ascertain more information regarding total quantity of narcotics used post-operatively to aid in 
prescribing patterns. 
 
 
1.2. Clinical Data to Date 
Cold therapy, such as ice packs or cold gel packs, has been shown to be an effective form of 
postoperative analgesia, with benefits seen in sports medicine, orthopedic surgery, hernia repair, 
maxillofacial surgery and even after abdominal surgery.1,2,10,11,12,13 Demonstrated benefits of cold 
therapy include decreased pain scores, decreased narcotic use and improved quality of life 
scores.1,2,10,11,12,13 Watkins et al performed a randomized control trial demonstrating decreased 
postoperative pain scores and narcotic demands in patients whom applied ice packs to their 
abdominal incision after laparotomy, when compared with a control group.1 There were no adverse 
side effects and no reports of thermal injury associated with the ice packs.1  
1.3 Dose Rationale and Risk/Benefits  
Previous studies have demonstrated that after laparoscopic gynecologic surgeries and specifically after 
laparoscopic hysterectomy, patients’ pain scores are highest on postoperative (POD) #0-1, that many 
patients take narcotics through POD#3, and that most patients are off of narcotics by POD#4.4 Since we 
aim to examine if cold therapy affects postoperative pain scores or narcotic use, we will instruct patients 
in the experimental group to use ice packs, as an adjunctive analgesic therapy for the first three days post-
operatively. Literature suggests that an application time of 20-30 minutes is recommended for beneficial 
effect of cold therapy, while minimizing the risk of any adverse reactions from cold application.11 We will 
therefore instruct patients to apply cold therapy for 20-30 minutes to abdominal incisions every 6 hours 
for the first three days of surgery. The 6-hour interval is to simplify dosing, as scheduled postoperative 
analgesic medications are also dosed every 6 hours (i.e. acetaminophen and ibuprofen). Risks of thermal 
injury from intermittent cold therapy are very low.1, 10, 11, 12   
1.4 Hypothesis 
Following laparoscopic hysterectomy, the prescription of cold therapy as an adjunctive analgesic agent to 
routine multi-modal analgesia, will decrease patients’ reported postoperative pain scores.  

 
 
 
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2.0 STUDY OBJECTIVES 
Primary Objective 
The primary objective of the study is to evaluate postoperative pain scores following laparoscopic 
hysterectomy, to determine if there is a difference in pain scores with the application of cold therapy 
to abdominal incisions, when compared to no cold therapy in the experimental and control groups at 
24 and 72 hours, respectively. The pain scores at 24 and 72 hours will be compared between the 
control and experimental groups.  
 
Secondary Objectives 
• 
To compare the amount of patient reported narcotics used for post-operative analgesia (in 
morphine equivalents) between the study and control groups at 24 and 72 hours after surgery.  
• 
To compare postoperative quality of life scores between the study and control groups using 
the validated Abdominal Surgery Impact Scale15 at 72 hours after surgery.  
• 
To compare postoperative recovery scores between the study and control groups using the 
validated Surgical Recovery Scale (SRS)19 10-14 days after surgery.  
 
Tertiary Objective 
To ascertain the mean and median patient reported total amount of narcotics used post-operatively (in 
morphine equivalents), collected at the 10-14 day postoperative visit in all patients. This data will be 
collected and reported in an effort to help guide prescribing practices of narcotic medications 
following laparoscopic surgery.  
 
 
3.0 STUDY DESIGN 
3.1  General Design 
The study design is a randomized controlled trial examining post-operative pain scores and 
outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to 
routine post-operative multi-modal analgesia, compared to those patients prescribed routine 
multi-modal analgesia without cold therapy. All patients scheduled for total laparoscopic 
hysterectomy (without robotic-assistance) will be screened for eligibility in the study. If 
eligible, patients will be invited to participate in the study and standardized informed consent 
process will ensue.  
All research activities will commence on the day of surgery, in the preoperative preparation 
area. Enrolled subjects will undergo standard registration and preoperative preparation by the 
staff preoperative nurse, including placement of intravenous access line and administration of 
standard routine preoperative medications. Preoperative medications (unless contraindicated 
due to patient allergy) include single dose prophylactic antibiotics given prior to surgical 
incision, Dexamethasone 10mg IV (unless the patient is diabetic), Ondansetron 4mg IV and 
Gabapentin 600mg PO given in the preoperative preparation area.20, 21 Patients with a 
preoperative Caprini score of 5 of greater will also receive Heparin 5000 units subcutaneous, 
for DVT prophylaxis. Deviation from standard preoperative medications will be recorded. 
While in the pre-operative area, and prior to any sedative drug administration by anesthesia, 
the patient will complete an 11-point Numeric Rating Scale (NRS) to record baseline pain, as 
well as a baseline 18-question quality of life survey with the Abdominal Surgery Impact 
Scale (ASIS). Both study instruments will be self-administered by the patients and collected 
by the research team.  

 
 
 
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The patient will then be moved to the operating room. Induction, intubation and anesthesia 
administration will be performed according to standard practice by a dedicated group of 
anesthesia providers. Anesthesia providers familiar with the protocol will administer 
anesthesia per routine practice, using short acting agents to allow for rapid awakening and 
lung protective ventilation (tidal volumes of 5-7ml/kg with a PEEP of 4-6cm H20) whenever 
possible or unless contraindicated.20 Prior to surgical incision, preoperative prophylactic 
antibiotics will be administered. The patient will be positioned in the dorsal lithotomy 
position with bilateral upper extremities in a tucked position. Surgical sterile preparation and 
draping will be performed per usual technique.  
Laparoscopic entry will typically be obtained by 5mm optical trocar in the periumbilical 
region, but placement may be modified at the surgeon’s discretion. Pneumoperitoneum will 
be established through this trocar to 15mmHg. Three additional laparoscopic trocars will be 
placed in one of two configurations, as per primary surgeon preference accounting for size of 
uterine pathology. The skin and subcutaneous tissue will be infiltrated with 1% lidocaine with 
epinephrine for local anesthetic prior to all skin incisions and port placement. The patient will 
be placed in Trendelenburg position and the surgery will be performed and completed in 
typical fashion. Upon conclusion of the procedure total operative time, estimated blood loss 
(EBL), total skin incision number and cumulative incision length will be recorded. If a mini-
laparotomy was created for transabdominal tissue extraction, incision location and length will 
also be recorded. All skin incisions will be closed in a subcuticular fashion and sealed with 
skin adhesive. 
Randomization will occur after the patient’s last skin incision is dressed with skin adhesive, 
indicating conclusion of the procedure. If randomized to the experimental group, cold gel 
pack(s) will be placed over the patient’s abdominal incisions prior to leaving the operating 
room. If randomized to the control group, no additional treatment will take place outside of 
routine postoperative monitoring and management.  
The patient will emerge from anesthesia under routine monitoring and will be transferred to 
the post-anesthesia care unit (PACU) when meeting appropriate criteria per anesthesia 
discretion. A staff PACU nurse will care for the patient in the PACU and administer one dose 
of Toradol 30mg IV, as well as narcotic medications as necessary and/or per patient request. 
All pain medications administered in the hospital will be recorded in the Epic electronic 
health record (EHR). The amount of each patient’s narcotic administration will be recorded 
from the EHR and documented in study files. We are unable to blind the staff PACU nurse to 
patient group allocation given the nature of the intervention. All patients will remain in 
PACU until meeting PACU discharge criteria and will be discharged to home on POD#0 with 
postoperative instructions for analgesic medications and cold therapy if applicable. If patients 
are unable to be discharged home, they will stay overnight in the hospital with documented 
rationale.   
All patients will be discharged home with uniform medication prescriptions as well as a daily 
Pain Score and Intervention Log (PSIL) to document medication/intervention use. All 
patients will receive written instructions for medication use (see attached). The experimental 
group will also receive written instructions for scheduled cold therapy use, to be used 
concomitantly with scheduled analgesics, as indicated below. All patients will be discharged 
home with prescriptions for Ondansetron 4mg PO every 8 hours as needed for 
nausea/vomiting (quantity 12), Colace 100mg PO twice daily (quantity 60), scheduled 
Ibuprofen 600mg PO every 6 hours (quantity 30), scheduled acetaminophen 650mg PO every 
6 hours (quantity 30), and oxycodone 5mg PO every 4 hours as needed for breakthrough pain 
(quantity 30). The experimental group will also receive reusable cold gel packs with 
instructions to apply cold therapy to abdominal incisions every 6 hours for 20-30 minutes 

 
 
 
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through POD#3. The rational for cold pack use through POD#3 is that most patients are off of 
narcotic pain medications by POD#44.  Scheduled ibuprofen and acetaminophen dosing is 
based on literature supporting that acetaminophen and ibuprofen should be used together16, 
and that clinicians should routinely incorporate around-the-clock non-opioid analgesics and 
non-pharmacologic therapies into multimodal analgesia regimens5.  
Approximately 24 hours after surgery, the patient will be contacted by a research team 
member who will administer an NRS pain survey via telephone and ask patient to report total 
number of narcotic pills used since discharge. If patient is still in the hospital, narcotic usage 
will be obtained from the EHR.  
Approximately 72 hours after surgery, the patient will be contacted by a research team 
member who will administer an NRS pain survey, an ASIS quality of life via telephone. 
Patient will again be asked to report total number of narcotic pills use since discharge.  
Per standard routine care, the patient will be asked to return to clinic 10-14 days after surgery 
for evaluation and examination. Patients will be asked to turn in PSIL at this visit. They will 
also be asked to complete a Surgical Recovery Scale (SRS). They will be asked to bring their 
narcotic prescription bottle to count the total number of narcotic pills remaining at the time of 
their two week visit. They will be asked if they are still taking the narcotic medication. If 
patients received a refill for narcotic medications prior to postoperative visit, counts will 
occur in the same manner accounting for additional pills, and it will be recorded in study 
data. The patient will exit the study after this visit.  
 
 
 
 
3.2  Primary Study Endpoints 
The primary objective of the study is to evaluate postoperative pain scores on a validated 11 point 
NRS14 at 24 and 72 hours for patients who have undergone laparoscopic hysterectomy. Pain 
scores at 24 and 72 hours will be compared between the control group and the experimental 
group. The 11-point NRS scale consists of whole number responses from zero (0) to ten (10).  
The NRS scale will be used versus a visual analog scale (VAS) as it can also be administered by 
telephone (important to secondary endpoints). 
 
3.3  Secondary Study Endpoints 
1. As pain scores from the NRS may represent controlled or uncontrolled pain, total narcotic 
usage will also be collected at 24 and 72 hours. Narcotic usage will be tracked by patient 
using their PSIL, and reported by patient during follow-up phone call.  Patients will be 
asked to provide the total number of narcotic pills remaining in their bottle. Amount of 
narcotic usage will be converted to intravenous morphine equivalents for comparison 
purposes. The patient reported values will be compared with their PSIL when turned in at 
their post-operative visit.  
2. Quality of life will be measured with the Abdominal Surgery Impact Scale (ASIS). It 
covers six domains including physical limitations, functional impairment, pain, visceral 
function, sleep, and psychological function.  Three items in each domain create a total of 
18 items, and this instrument has been previously validated15 with its design for use in 
open or laparoscopic abdominal surgery in determining health-related post-operative 
quality of life.  Subject responses to each item are on a seven-point Likert scale ranging 

 
 
 
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from 1 to 7.  The possible total score ranges from 18 to 126, with higher scores reflecting 
improved quality of life. Patients are instructed to respond based on their feelings for the 
immediately preceding 24 hours.  This instrument will be self-administered in the pre-
operative area the day of surgery, and again at 72 hours post-operatively by the research 
team via a telephone call.    
3. Postoperative recovery scores will be measured using the Surgical Recovery Score 
(SRS).19 The aim of the tool is to reliably measure functional patient recovery following 
surgery. It provides an outcomes measure against which interventions used to enhance 
recovery can be assessed, and this instrument has been previously validated19 with its 
design for use in open or laparoscopic abdominal surgery. There are 13 SRS items, all of 
which are scored from 0 to 5, or 0 to 4, with total scores ranging from 0 to 60, with 
higher scores indicating better recovery. Patients are instructed to respond based on their 
feelings for the preceding two days. The instrument with be administered by the research 
team at their 10-14 day post-operative visit.   
 
4. Total narcotics used postoperatively will be measured at the 10-14 day postoperative 
visit. Patients will be asked to bring their narcotic pill bottle to their post-operative visit. 
Total narcotic pill use will be calculated by counting the number of pills remaining in 
their bottle and compared with their PSIL. Total narcotic usage will be converted to 
intravenous morphine equivalents for comparison purposes. This data will be collected 
and reported in an effort to help guide prescribing practices for narcotic medications 
following laparoscopic surgery.  
 
 
3.4  Primary Safety Endpoints 
All complications including but not limited to vascular, bladder, ureter, and intestinal injury, need for 
blood transfusion, venous thromboembolism, or other cardiac and respiratory complications within 
the first 30 days after surgery will be recorded.  Total procedure time and estimated blood loss will 
also be recorded throughout the study. Any adverse events related to cold therapy use will be 
documented and reported, and in the event of severe adverse reactions will be treated appropriately 
and cold therapy will be immediately stopped in that patient.  
 
4.0 SUBJECT SELECTION AND WITHDRAWAL 
4.1 Inclusion Criteria 
Subjects must meet the following inclusion criteria to be eligible for study enrollment:  
1. Patients can understand and voluntarily sign an informed consent form 
2. Female gender ages 18-65 
3. Scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without 
or without oophorectomy (standard of care involves bilateral salpingectomy) 
4.2 Exclusion Criteria 
Meeting any of the following exclusion criteria will make the subject ineligible for study 
enrollment: 
1. Conversion to laparotomy 
2. Diagnosis of chronic pelvic pain 

 
 
 
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3. No access to freezer at home to keep reusable cold packs cold between uses 
4. Contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, 
Raynaud’s disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum) 
5. Medical contraindication to NSAID use 
4.3 Subject Recruitment and Screening 
All patients scheduled for laparoscopic hysterectomy are typically seen in clinic within 30 days of 
surgery for a pre-operative appointment.  If meeting inclusion criteria, they will be introduced to the 
study by a member of the research team in the clinic room following their appointment.  Confirmation 
will be made by the research team that the patient does not have a previous diagnosis of chronic pelvic 
pain, that the patient has access to a freezer postoperatively, that the patient has no contraindications 
to exposure to cold therapy and that the patient has no medical contraindication to NSAID use. If 
agreeable to participation, an informed consent form will be signed that day.  If unable to discuss the 
study during the pre-operative appointment, a member of the research team will call the patient by 
telephone to introduce them to and discuss the study.  If the patient is agreeable to enrollment verbal 
consent and conversation will be documented in the EHR, and the informed consent document will be 
signed the day of surgery, after again reviewing the risks and benefits of the study. 
 
4.4 Early Withdrawal of Subjects 
Patients may withdraw from the trial at any time and for any reason. Some possible reasons for early 
withdrawal include the following: 
§ 
Development of an intercurrent medical condition or need for concomitant treatment that          
precludes further participation in the trial (such as surgery for other indications or trauma) 
§ 
Unacceptable toxicity or any adverse event that precludes further participation in the trial 
§ 
The investigator removes the patient from the trial in the best interests of the patient 
§ 
Study completion or discontinuation 
§ 
Patient withdraws consent to continued participation in the trial 
§ 
If the procedure cannot be completed by laparoscopy and is converted to laparotomy, patient will 
be removed from the study by the research team, prior to randomization 
 
4.5 Data Collection and Follow Up for Withdrawn Subjects 
As above, subjects may withdraw at any time, or for above listed conditions. Subjects may choose if 
any data collected prior to withdrawal can be used in data analysis.  If withdrawn subjects do not want 
data included in analysis, it will be discarded safely.  Follow-up will consist of standard care with 
post-operative clinic visits at 10-14 days and 6 weeks.  If patients withdraw after surgery, we will ask 
to review their chart for morbidity or mortality within 30 days of surgery.  
 
5.0 STUDY DRUG (or Device, Biologic, Treatment) 
5.1 Description 
The study intervention is cold therapy administered via reusable cold gel packs. The intervention is 
not experimental. Cold therapy has been shown to be an effective form of postoperative analgesia, it 
just has not been evaluated after laparoscopy, to the best of our knowledge.1,2,10,11,12,13 
5.2 Treatment Regimen 

 
 
 
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Previous studies have demonstrated that after laparoscopic gynecologic surgeries and specifically 
after laparoscopic hysterectomy, patients’ pain scores are highest on postoperative days(POD) 0-
1, that many patients take narcotics through POD#3, and that most patients are off of narcotics by 
POD#4.4 Since we aim to examine if cold therapy affects postoperative pain scores or narcotic 
use, we will instruct patients in the experimental group to use ice packs, as an adjunctive 
analgesic therapy for the first three days post-operatively. Literature suggests that an application 
time of 20-30 minutes is recommended for beneficial effect of cold therapy, while minimizing the 
risk of any adverse reactions from cold application.11 We will therefore instruct patients to apply 
cold therapy for 20-30 minutes to abdominal incisions every 6 hours for the first three days of 
surgery. The 6-hour interval is to simplify dosing, as scheduled postoperative analgesic 
medications are also dosed every 6 hours (i.e. acetaminophen and ibuprofen). Patients may use 
the cold therapy more frequently if desired. Risks of thermal injury from intermittent cold therapy 
are very low.1, 10, 11, 12 Previous studies have resulted in no adverse side effects and no reports of 
thermal injury associated with cold packs applied to the abdomen postoperatively.1  
 
5.3 Method for Assigning Subjects to Treatment Regimen 
Subjects will be assigned a sequential research ID number at time of enrollment (in clinic or by 
telephone).  A randomized list will be created in blocks of  4 and 6 with Sealed Envelope (Sealed 
Envelope Ltd. 2015. Simple randomization service. Available from: 
https://www.sealedenvelope.com/simple-randomiser/v1/).  Group assignment will be written on a card 
and placed in a numbered (corresponding to research ID number), opaque envelope.  Envelopes will 
be opened by the research team in the operating room at the conclusion of the operation to reveal 
randomization. Randomization will be stratified to include equal numbers of patients with and without 
mini-laparotomy incisions enrolled in both the treatment and control group. Patients with pre-
operative uterine size measuring 16 weeks or greater in size will be presumed to require a mini-
laparotomy incision for tissue extraction. This is generally routine practice within our group for tissue 
extraction. If however mini-laparotomy is not required surgically, and we are able to remove the 
specimen vaginally, the randomization stratification will not change. This will be in an effort to 
maintain equal number of patients undergoing mini-laparotomy or not, in both the control and 
treatment group.  
 
5.4 Preparation and Administration of Study Treatment 
After randomization, the study group participants will receive cold gel pack(s) to be applied to 
abdominal incisions beginning either in the operating room or no later than while the patient is in the 
PACU. They will also receive additional written instructions on cold therapy use as previously 
described (please see attached documents for written patient instructions). The cold therapy packs will 
be kept cold in a designated freezer to be readily available postoperatively. The cold gel pack and 
written instructions will be delivered by a research team member to patients randomized to the study 
group. Patients will be instructed to call primary co-investigator immediately should patients 
experience any adverse side effects or event related to the cold therapy and to discontinue use of cold 
therapy until addressed by research team member. All such instances will be recorded in research 
data.   
 
5.5  Subject Compliance Monitoring 
Subject compliance will be tracked using the PSIL that will be provided to all patients on POD#0 
prior to discharge to home (please see attached). Patients will receive written instructions for 

 
 
 
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recording cold therapy use as well as medication use and pain scores. Patients using cold therapy will 
be considered compliant if they use the cold therapy intervention at least 75% of the suggested time, 
which includes every 6 hours for the first 72 hours. This compliance will be recorded and reported as 
necessary. 
 
5.6 Prior and Concomitant Therapy 
Patients in both the control and experimental group will receive concomitant medical therapy by means 
of routine postoperative analgesia as described above in section 3.1. All patients will be discharged 
home with uniform medication prescriptions as well as a daily Pain Score and Intervention Log 
(PSIL) to document medication/intervention use. All patients will receive written instructions for 
medication use (see attached). All patients will be discharged home with prescriptions for 
Ondansetron 4mg PO every 8 hours as needed for nausea/vomiting (quantity 12), Colace 100mg PO 
twice daily (quantity 60), scheduled Ibuprofen 600mg PO every 6 hours (quantity 30), scheduled 
acetaminophen 650mg PO every 6 hours (quantity 30), and oxycodone 5mg PO every 4 hours as 
needed for breakthrough pain (quantity 30). Scheduled ibuprofen and acetaminophen dosing is based 
on literature supporting that acetaminophen and ibuprofen should be used together16, and that 
clinicians should routinely incorporate around-the-clock non-opioid analgesics and non-
pharmacologic therapies into multimodal analgesia regimens5. Use of the above concomitant 
medications will be documented in the PSIL administered to all patients, specific to their 
randomization group. Control group patients will be requested to not use cold therapy as it is not a 
routinely recommended intervention and is the study intervention.  
 
5.7 Blinding of Study Drug (Device or Treatment) 
We are unable to blind the study participants given the nature of the intervention.  
 
 
6.0 STUDY PROCEDURES 
 
6.1 
Pre-registration and Screening  
This will occur at the pre-operative clinic appointment within 30 days of surgery, or by telephone call 
prior to, but within 30 days of surgery.  Screening will occur to ensure patient meets all inclusion 
criteria and no exclusion criteria. Informed consent signing will occur at this clinic visit, or the day of 
surgery if enrolled verbally by telephone. 
 
6.2 
Pre-operative, Day of Surgery 
Patient will undergo routine registration and surgical readiness by a staff pre-operative nurse.  The 
research team assistant will administer an NRS pain survey and an ASIS quality of life survey.  
 
6.3 
Intra-operative, Day of Surgery 
The subject will undergo laparoscopic hysterectomy according to standard routine.  After completion 
of the surgical procedure, randomization will occur. If randomized to the experimental group, cold 
therapy will be initiated either in the operating room or no later than upon arrival to PACU. Surgical 
data will also be collected as described in section 3.1.  
 
6.4 
24 Hours Post-operatively 

 
 
 
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A research team member or research assistant will contact the patient 24 hours after surgery by 
telephone (or in person if patient is still hospitalized).  An NRS pain survey will be administered by 
the team member or assistant, who will also record responses on the reporting form.  Subjects will 
also be asked to report number of narcotic pills used since discharge and associated dosages. 
 
6.5 
72 Hours Post-operatively  
A research team member or assistant will contact the patient 72 hours after surgery by telephone (or in 
person if patient is still hospitalized).  An NRS pain survey and an ASIS quality of life survey will be 
administered by the research team member or assistant, who will also record responses on the 
designated reporting forms.  Subjects will also be asked to report number of narcotic pills used since 
discharge and associated dosages. 
 
6.6 
10-14 Day Post-operative Visit 
Standard evaluation and examination will occur at this visit.  The research team member or assistant 
will collect the patient’s PSIL as well as count and record the total number of narcotic pills remaining 
in the patient’s pill bottle. It will be recorded if the patient is still taking the narcotic pain medication. 
It will also be recorded if the patient has required a refill of narcotic medication prior to post-operative 
visit. The patient will also be asked to complete a Surgical Recovery Scale (SRS) survey. 
 
6.7 
Study Calendar of Procedures  
 
 
Pre-Study Pre-Op 
Intra-Op 
24 hrs  
Post-Op 
(Phone) 
72 hrs  
Post-Op 
(Phone) 
10-14d 
Post-Op 
(Clinic) 
ENROLLMENT 
X 
 
 
 
 
 
INFORMED 
CONSENT 
X 
 
 
 
 
 
DEMOGRAPHICS 
X 
 
 
 
 
 
MEDICAL HX 
X 
X 
 
 
 
X 
PHYSICAL EXAM  
X 
X 
 
 
 
X 
PAIN NRS SURVEY 
 
X 
 
X 
X 
 
ASIS QoL SURVEY 
 
X 
 
 
X 
 
RANDOMIZATION 
 
 
X 
 
 
 
NARCOTIC DATA  
 
 
 
X 
X 
X 
SRS SURVEY 
 
 
  
 
 
X 
COLLECT PSIL 
 
 
 
 
 
X 
 
• 
Pre- study evaluations must be performed within 30 days of surgical procedure. 
 
7.0 STATISTICAL PLAN 
7.1 
Sample Size Determination 

 
 
 
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Although cold therapy has been found to be effective in other post-operative patient 
populations and in other medical settings, such as sports medicine, there is no previous 
literature, to the best of our knowledge, evaluating the use of cold therapy after laparoscopic 
surgery. For this reason we plan to perform a pilot study for initial determination of a statistical 
difference in post-operative pain outcomes. We plan to enroll 28 patients in each arm, stratified 
to 14 patients with mini-laparotomy incisions and 14 patients without mini-laparotomy 
incisions, for a total of 56 patients. 56 patients will allow the pilot study to be completed in a 
reasonable time frame.  
 
7.2 
Statistical Methods 
After all data has been collected, demographic, preoperative and intraoperative data will be 
summarized overall and by randomized group, using frequencies and percentages for categorical 
factors, and means and standard deviations for continuous measures. Primary outcome data will be 
analyzed using Mann-Whitney test for continuous nonparametric data. Secondary continuous 
outcomes data will analyzed using means and an unpaired t-test. Tertiary outcome data will simply 
be recorded and reported. All data collected will be recorded and stored in RedCap.  
 
7.3 
Subject Population(s) for Analysis 
The all-treated population will be used for data analysis for primary, secondary and tertiary objectives.  
Inter-group analyses will occur as listed in the primary objective (Section 2.0).   
If patients are not able to be contacted for the 24 hour or 72 hour post-operative phone call 
assessments, or 10-14 day post-operative visit, they will not be included in analyses of these data 
alone. 
 
8.0 SAFETY AND ADVERSE EVENTS 
8.1 
Definitions 
An adverse event (AE) is any untoward or unfavorable medical occurrence, symptom, disease, 
abnormal physical exam finding, or abnormal laboratory result which occurs to a participant in 
research conducted by Cleveland Clinic Florida.  Psychological harms also constitute adverse 
events.   
 
A serious adverse event (SAE) is an adverse experience that results in any of the following 
outcomes: 
• 
Death 
• 
A life-threatening experience 
• 
Inpatient hospitalization or prolongation of existing hospitalization 
• 
A persistent or significant disability / incapacity. 
 
8.2 
Recording of Adverse Events 
At each contact with the subject, the investigator will seek information on adverse events by specific 
questioning and, as appropriate, by examination. Information on all adverse events will be recorded 
immediately in the source document, and also in the appropriate adverse event section of the case 
report form (CRF).  All clearly related signs, symptoms, and abnormal diagnostic procedures results 
will also be recorded in the source document.  

 
 
 
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The clinical course of each event will be followed until resolution, stabilization, or until it has been 
determined that the study treatment or participation is not the cause. Serious adverse events that are 
still ongoing at the end of the study period will be followed up to determine the final outcome. Any 
serious adverse event that occurs after the study period and is considered to be possibly related to the 
study treatment or study participation will be recorded and reported immediately. 
 
8.3 
Reporting of Serious Adverse Events 
8.3.1 
IRB Notification by Investigator 
Reports of all serious adverse events (including follow-up information) will be submitted to the CCF 
IRB per guidelines in the CCF IRB Standard Operating Procedures manual.  The following four types 
of events will be reported to the IRB:  
1. Adverse events which are serious, unexpected, and related or possibly related to participation 
in the research.  
2. Serious adverse events that are expected in some subjects, but are determined to be occurring at 
a significantly higher frequency or severity than expected.  
3. Other unexpected adverse events, regardless of severity, that may alter IRB analysis of the risk 
versus potential benefit of the research and, as a result, warrant consideration of substantive 
changes in the research protocol or informed consent process/document.  
4. Unanticipated Problems involving risks to subjects or others or any serious or continuing 
noncompliance with this policy or the requirements or determinations of the IRB. 
 
8.4 Stopping Rules 
An interim analysis of the patient data will be performed when 50% of the patients have completed 
the study.  If a statistically significant proportion of patients have had adverse reactions or serious 
adverse reactions due to the study intervention of cold therapy, the study will halt.  If any adverse 
outcome is fatal, the study will immediately halt and the IRB will be notified.  In the case that the 
study is stopped then the IRB will be notified.   
 
8.5 Medical Monitoring 
The Principal Investigator with the research team will hold responsibility for monitoring of post-
operative complications.  As the research intervention only involves application of cold therapy to 
abdominal incisions, only potential adverse effects of cold therapy are expected as compared to the 
control group.  Careful monitoring for adverse events will occur with assurance that reporting follows 
the above guidelines.  The number and type of adverse events will be recorded in the case report 
forms.  Diligence will be maintained to observe for any known complication of laparoscopic 
hysterectomy in all patients.  Any SAE will be reported to the IRB as listed above in section 8.3.1. 
 
9.0 DATA HANDLING AND RECORD KEEPING 
9.1 
Confidentiality and Privacy 
Information about study subjects will be kept confidential and managed according to the Health 
Insurance Portability and Accountability Act of 1996 (HIPAA). An informed consent document will 
be signed by all patients prior to surgery and will list 
• 
What protected health information (PHI) will be collected from subjects in this study 
• 
Who will have access to that information and why 

 
 
 
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• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke authorization for use of PHI.  
 
Only the enrollment log will contain identifiable personal health information including the patient’s 
name and assigned research identification number.  This will be kept on a secure Cleveland Clinic 
Florida drive, and a paper copy will be kept in a locked filing drawer in the research team’s office on 
the Cleveland Clinic Florida property.  The CRFs will only contain research identification numbers 
without protected health information.  These will also be kept in a locked file.  The data from the 
CRFs will be entered online into a RedCap database by a member of the research team. Only 
members of this research team will have access to this information. 
 
9.2 
Source Documents 
Source data will include the electronic health record for patient demographics, history and physical 
exams, operative notes, progress notes from post-operative visits, anesthesia records, vitals, and 
events related to the surgery. Pertinent information will be pulled from the electronic health record 
onto the CRFs.  The questionnaires completed by patients will be kept in a locked filing drawer in the 
research team’s office on the Cleveland Clinic Florida property. 
Source data is all information, original records of clinical findings, observations, or other activities in 
a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in 
source documentation. Examples include but are not limited to: original documents, hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, copies or transcriptions of electronic records certified after verification 
as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-
rays, subject files, and records kept at the pharmacy and laboratories, etc.  
 
9.3  Case Report Forms 
The attached case report form will have spaces for documentation of demographics, baseline pain 
scores and survey results, surgical data, post-operative pain scores and survey results, and post-
operative narcotic use. The ASIS and SRS survey will be kept as an appendix to the CRF for each 
patient.  This data will be transcribed to a secure RedCap database for analysis by a member of the 
research team.  
9.4 
Records Retention 
Data within the EHR will exist in its perpetuity, as will the secure files on the Cleveland Clinic 
server (at least 6 years after study completion).  All consent documents, case report forms, and 
QOL surveys will be maintained in a secure file cabinet within the Department of Gynecology at 
Cleveland Clinic Florida for at least 6 years. 
 
10.0 
STUDY MONITORING, AUDITING AND INSPECTING 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, government 
regulatory bodies, and Institutional compliance and quality assurance groups of all study related 
documents (for example, source documents, regulatory documents, data collection instruments, study 
data etc.). The investigator will ensure the capability for inspections of applicable study-related 
facilities. Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable Institutional compliance and quality assurance 
offices. 

 
 
 
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11.0 
ETHICAL CONSIDERATIONS 
This study will be conducted according to US and international standards of Good Clinical Practice 
(FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable 
government regulations and Institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted independent 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal approval of 
the study conduct. The decision of the IRB concerning the conduct of the study will be made in 
writing to the investigator prior to commencement of the study. 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision. 
 
12.0 
PUBLICATION PLAN 
Neither the complete nor any part of the results of the study carried out under this protocol will be 
published or passed on to any third party without the consent of the study investigators.  The 
investigators alone hold responsibility for publication of study data and results. 
 
13.0 
REFERENCES 
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Kooby DA, Maithel SK, Staley CA, Master VA. Ice packs reduce postoperative midline incision pain 
and narcotic use: a randomized controlled trial. J Am Coll Surg. 2014 Sep;219(3):511-7. 
2. Holder KA, Dougherty TB, Porche VH, Chiang JS. Postoperative pain management. Int Anesthesiol 
Clin. 1998 Summer;36(3):71-86. 
3. Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101910:77-86. 
4. El Hachem L, Acholonu UC Jr, Nezhat FR. Postoperative pain and recovery after conventional 
laparoscopy compared with robotically assisted laparoscopy. Obstet Gynecol. 2013 Mar;121(3):547-
53. 
5. Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy 
CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, 
Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, 
Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the 
American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the 
American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, 
and Administrative Council. J Pain. 2016 Feb;17(2):131-57. 
6. Sun EC, Darnall B, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use 
Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Jul 11. 
7. Bates C, Laciak R, Southwick A, Bishoff J. Overprescription of postoperative narcotics: a look at 
postoperative pain medication delivery, consumption and disposal in urological practice. J Urol. 2011 
Feb; 185(2):551-5. 
8. Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced Recovery Pathways for 
Improving Outcomes After Minimally Invasive Gynecologic Oncology Surgery. Obstet Gynecol. 2016 
Jul;128(1):138-44. 
9. Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, 
Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in 
gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS®) Society 
recommendations - Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. 

 
 
 
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Aug;6(4):193-200.  
11. Koç M, Tez M, Yoldaş O, Dizen H, Göçmen E. Cooling for the reduction of postoperative pain: 
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12. Ibikunle AA, Adeyemo WL. Oral health-related quality of life following third molar surgery with or 
without application of ice pack therapy. Oral Maxillofac Surg. 2016 Sep;20(3):239-47. 
13. Kuyucu E, Bülbül M, Kara A, Koçyiğit F, Erdil M. Is cold therapy really efficient after knee 
arthroplasty? Ann Med Surg (Lond). 2015 Nov 11;4(4):475-8. 
14. Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy 
CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, 
Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, 
Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the 
American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the 
American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, 
and Administrative Council. J Pain. 2016 Feb;17(2):131-57. 
15. Urbach DR, Harnish JL, McIlroy JH, Streiner DL. A measure of quality of life after abdominal 
surgery. Quality of Life Research(2006)15:1053-1061 
16. Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with 
nonsteroidal anti-inflammatory drugs: a qualitative systematic review of analgesic efficacy for acute 
postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. 
17. Betcher RE, Chaney JP, Lacy PR, Otey SK, Wood DJ. Analysis of postoperative pain in robotic 
versus traditional laparoscopic hysterectomy. J Robot Surg. Epub 2013 Jun 5. 
18. Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a 
reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. 
19. Paddison JS, Sammour T, Kahokehr A, Zargar-Shoshtari K, Hill AG. Development and validation of 
the surgical recovery scale (SRS). J Surg Res. 2011;167(2):e85-91. 
20. Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, 
Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in 
gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERASÒ) Society 
recommendations – Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. 
21. Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, 
Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries, Effect of Care 
Standardization. Obstet Gynecol. 2016 Sept;128(3):457-466. 
 
 
14.0 
ATTACHMENTS 
• 
Feasibility Checklist 
• 
Informed Consent Form 
• 
Case Report Form 
• 
Abdominal Surgery Impact Scale 
• 
Surgical Recovery Scale 
• 
Pain Score and Intervention Log 
• 
Postoperative Instructions for Control Group 
• 
Postoperative Instructions for Study Group