Predictors of Postoperative Pain in Urogynecologic Surgery
Conditions: Postoperative Pain
Sponsor: TriHealth Inc.

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RESEARCH PROTOCOL 
 
Date 
11-28-16 
Title 
Predictors of Postoperative Pain in Urogynecologic Surgery 
Principal Investigator 
Rachel N. Pauls, MD 
Sub-Investigators 
Abigail Shatkin-Margolis, MD; Christopher Morrison, MD; Steven D. 
Kleeman, MD; Catrina C. Crisp, MD, MSc; Jennifer Yeung, DO; 
Benjamin Smith, MD 
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
16-093 
 
Purpose of Study    
• Postoperative pain remains the most important consideration for both patients and 
surgeons. A previous qualitative systematic review has identified preoperative pain, 
anxiety, age, and type of surgery as significant predictors of postoperative pain (Ip, 
Abrishami, Peng, Wong, & Chung, 2009). 
• The purpose of this study is to determine the predictors of postoperative pain 
specific to the urogynecologic patient population. Such information would allow 
urogynecologists to tailor their preoperative counseling to provide more accurate 
expectations regarding postoperative pain. 
o Primary Aim:  To determine if there is any relationship between preoperative 
factors (such as demographic information, medical history, disease burden), 
perioperative factors (such as length of surgery, blood loss) and postoperative 
pain scores with patients who have undergone urogynecologic surgery, 
specifically vaginal reconstruction for pelvic organ prolapse.  
 
Hypothesis or Research Question  
• We hypothesize that several perioperative factors (specifically age, BMI, medical and 
psychiatric history, prolapse stage, length of case, etc.) will be correlated with 
increased postoperative pain in the urogynecologic patient population.  
 
Background  
Prescription opioid use has become a growing epidemic in recent years, especially here in Ohio 
(Prevention). From 1990 to 2010, drug overdose death rates in the United States have 
increased four-fold (3.4 to 12.4 per 100000 population).  Sadly, in 2009 the drug overdose 
death rate surpassed motor vehicle death rates for the first time in history (Center for Disease 
Control and Prevention). This opioid epidemic has been partly attributed to changes in medical 
professionals’ prescribing of opioids in an effort to treat noncancer pain more effectively 
(Maxwell, 2011). While the rampant opioid problem is obviously multifactorial, we as medical 
providers would be remiss if we did not take some responsibility. 
 

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Patients are prescribed opioids and other related narcotic medications for a myriad of reasons. 
However, in the sphere of urogynecology and pelvic floor dysfunction, opioids are primarily 
reserved for postoperative pain management. Postoperative pain is one of the most frequently 
reported postoperative symptoms (Chung, Un, & Su, 1996). Given this fact, there has been 
much attention brought toward investigating predictive factors of postoperative pain. A 
systematic review of 48 eligible studies with 23,037 patients showed preexisting pain, anxiety, 
age, and type of surgery are the four most significant predictive factors for the intensity of 
postoperative pain (Ip et al., 2009).  However this paper evaluated all types of surgical 
approaches.  More recently, a prospective observational study showed that preoperative State 
Trait Anxiety Inventory (STAI) and Numerical Rating Scales (NRS) for anxiety and pain 
expectations are independent predictors of pain and morphine consumption following 
abdominal hysterectomy (Aouad et al., 2016). 
 
To date, little is known about the predictive factors of postoperative pain in the urogynecologic 
patient population. We aim to investigate the relationship between perioperative factors (such 
as demographics and medical history) and patient-reported pain scores on postoperative day 1. 
This information would not only fill a gap in knowledge, but would also allow us to counsel our 
patients more accurately in regards to postoperative expectations. Furthermore, if we find any 
positive correlation between modifiable perioperative factors and postoperative pain scores, 
we may be able to minimize these effects in future surgical cases. In an era when the United 
States is declaring a national week of observation for Prescription Opioid and Heroin Epidemic 
Awareness (Obama, 2016), we as medical providers must continue our efforts to minimize one 
of the many culprits—postoperative pain. 
 
 
Research Plan  
• Study Design  
o Retrospective chart review 
 
• Setting for the study 
o The retrospective chart review will be performed on TriHealth EPIC and database 
platforms at one of the various clinical locations. 
 
• Participants 
o Study population:  All participants of previous IRB-approved research studies 
within the Division of Urogynecology and Reconstructive Pelvic Surgery that 
incorporated assessment of postoperative pain as part of the data collection. 
▪ Participants from the following studies:  Hatton #13090, #13072, #12136, 
#12132, #10072, and #09001 
▪ Previously developed databases from each of the above mentioned 
studies will be used to identify participants. 
o Inclusion criteria 
▪ Adults 18 years of age or older 

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▪ Participant in one of six research studies previously performed by the 
Division of Urogynecology and Pelvic Reconstructive Surgery (Hatton 
#13090, #13072, #12136, #12132, #10072, or #09001) 
▪ Postoperative pain scoring data complete and available 
▪ Vaginal reconstructive surgery as primary treatment 
▪ General anesthesia 
o Exclusion criteria 
▪ Incomplete or unavailable postoperative pain scoring 
▪ Robotic sacrocolpopexy patients will be excluded 
o Sample size 
▪ Given the number of participants in each of the previously performed 
studies, we estimate that there will be approximately 374 participants in 
this study.  
▪ A sample size calculation is not applicable given the retrospective nature 
of this study design. 
 
• Data Collection 
o Independent variables:  Age, BMI, race, gravidity/parity, past medical history, 
past surgical history, home medications, menopausal status, tobacco use, sexual 
activity, stage of pelvic organ prolapse, type of surgery, length of case, estimated 
blood loss, type of anesthesia, length of hospital stay, surgical complications and 
perioperative hemoglobin level. All of these variables will be obtained either 
from previous data records or from chart review. 
o Dependent variables:  Visual analog scale (VAS) pain score on postoperative day 
1 (POD1), Nursing verbal pain score, and narcotic use (morphine equivalents) in 
the first 24 hours and entire hospital stay. 
 
• Intervention or experimental aspect of the study 
o No intervention will occur as part of this study.  
o There are no potential risks to the study population by any aspect of the study. 
 
• Statistical Analysis 
o The primary outcome of this study is the VAS pain scores on POD1 and the 
association with various perioperative factors. Pearson product moment 
correlation coefficient will be employed to measure the association between 
VAS pain score and a continuous factor such as age, blood loss, or length of 
surgery.  If a factor is dichotomous (two categories, i.e. gender), point-biserial 
correlation coefficient will be used for investigating the association, and 
independent samples t test or Mann-Whitney U test will be also considered as 
well. For a factor having more than three categories, ANOVA or Kruskal-Wallis H 
test will be used to compare VAS scores among categories. 
  
 
 

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Ethical Considerations 
• Informed consent  
o Since this is a retrospective chart review, waivers of Informed Consent and 
Authorization will be requested. 
• Privacy information 
o Extensive efforts will be made to ensure and maintain participant 
confidentiality. All identifying information will be maintained in a secure area 
at all times. All communication between staff members regarding participant 
data will occur via the Hatton Study # and Subject ID number only. However, 
identifying information will be retained in the original/source documents. 
o The Excel spreadsheet will be stored on a password protected, encrypted 
TriHealth computer for ten years following study closure, and then purged. 
 
Cost/Budget 
• This study will incur no cost to the institution, the participants, or the investigators. 
 
Estimated Period of Time to Complete Study 
When will study begin? 
January 2017 
Protocol Development 
Completed 
2 weeks 
Admin Review Time 
2 weeks 
IRB Approval 
3 weeks 
Data collection 
4 weeks 
Data analysis 
4 weeks 
Presentation development 
(if applicable) 
2 weeks 
Manuscript Development 
(if applicable) 
4 weeks 
Journal submission process 
(if applicable) 
4 weeks 
Study closure 
2 weeks 
 
• When and how will results be disseminated? 
o The results will be disseminated by way of an oral or poster presentation at a 
national meeting, and with publication in a high-impact journal. 
 
 
 
 
 
 

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References 
 
Aouad, M. T., Kanazi, G. E., Malek, K., Tamim, H., Zahreddine, L., & Kaddoum, R. N. (2016). Predictors of 
postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. 
J Anesth, 30(1), 72-79. doi: 10.1007/s00540-015-2090-0 
Center for Disease Control and Prevention, N. C. f. H. S. Compressed Mortality File 1999-2010. 
http://wonder.cdc.gov/cmf-icd10.html, Accessed May 13, 2013.  
Chung, F., Un, V., & Su, J. (1996). Postoperative symptoms 24 hours after ambulatory anaesthesia. Can J Anaesth, 
43(11), 1121-1127. doi: 10.1007/BF03011838 
Ip, H. Y., Abrishami, A., Peng, P. W., Wong, J., & Chung, F. (2009). Predictors of postoperative pain and analgesic 
consumption: a qualitative systematic review. Anesthesiology, 111(3), 657-677. doi: 
10.1097/ALN.0b013e3181aae87a 
Maxwell, J. C. (2011). The prescription drug epidemic in the United States: a perfect storm. Drug Alcohol Rev, 
30(3), 264-270. doi: 10.1111/j.1465-3362.2011.00291.x 
Obama, B. (2016). Presidential Proclamation--Prescription Opioid and Heroin Epidemic Awareness Week, 2016. 
http://www.whitehouse.gov/the-press-office/2016/09/16/presidential-proclamation-prescription-opioid-
and-heroin-epidemic.  
Prevention, C. f. D. C. a. Injury Prevention & Controls: Opioid Overdose, State Data. 
http://cdc.gov/drugoverdose/data/statedeaths.html, Accessed November 16, 2016.