STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial
Phase: NA
Conditions: Postoperative Pain, Opioid Use, Prolapse; Female, Incontinence
Sponsor: The Cleveland Clinic

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Restrictive Opioid Prescribing after Surgery for Prolapse and Incontinence: A 
Randomized Controlled Trial 
 
The STandard versus No Opioid Prescription after Prolapse and Anti-INcontinence Surgery 
(STOP-PAIN) Trial 
 
Angela S. Yuan, MD; Fellow in Female Pelvic Medicine and Reconstructive Surgery. Center 
for Urogynecology and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women’s 
Health Institute at Cleveland Clinic 
 
Katie Propst, MD; Staff Physician, Center for Urogynecology and Pelvic Reconstructive 
Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland Clinic 
 
Graham Chapman, MD; Associate Staff Physician, Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Shannon Wallace, MD; Associate Staff Physician, Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Cecile A. Ferrando, MD, MPH; Assistant Professor. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute at Cleveland 
Clinic 
 
Background and Significance 
Over the past two decades, there has been a dramatic rise in the use of prescription opioids 
worldwide. Opioid overdoses accounted for more than 47,000 deaths in the United States in 
2017, more than any previous year on record1. Overprescribing opioids is considered a major 
contributor to the opioid crisis2. After pain medicine specialists, surgeons have the highest rate 
of opioid prescribing3. Hill et al. demonstrated that within a general surgery practice, over 70% 
of the prescribed opioid pills were never taken4. Disturbingly, 45% of patients who did not take 
opioids at all on their day of discharge were discharged with an opioid prescription5. Similar 
excess opioid prescribing practices have been described within gynecologic surgery6-7.  
The prescription of excess opioids, especially when none are needed to reasonably manage pain, 
is an alarming trend that demands attention. Lack of knowledge about patterns of postoperative 
opioid use, desire to minimize patient dissatisfaction during recovery, and avoiding the 
inconvenience of an office visit to obtain a prescription refill have all been cited as reasons for 
this practice2. Research has been conducted to improve knowledge of opioid usage after various 
operations. This has led to development of opioid prescribing guidelines by expert panel 
consensus; in one such guideline, the minimum recommended number of opioid tablets after 20 
different surgeries was zero, based off actual patient usage patterns and stakeholder input8.  
Recent initiatives have attempted to utilize restrictive opioid prescribing protocols for 
postoperative pain management. In a prospective study of 190 patients undergoing minimally 

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invasive general surgery and urology operations, patients were advised to use non-opioid 
analgesics and provided with a small (4-10 pills) rescue opioid prescription for breakthrough 
pain9. Fifty-two percent of patients used no opioids after surgery, and 98% of patients used 10 
pills or fewer. Patients still reported high satisfaction and pain control with this opioid-sparing 
pathway9. Another recently published large case-cohort study of over 1,200 gynecologic 
oncology surgery patients tested an opioid prescription protocol in which patients were not 
prescribed opioids at discharge unless they required more than 5 doses of opioids while in the 
hospital10. Investigators found a significant reduction in the number of dispensed opioids after 
implementation of this protocol, without any change in the number of refill requests, 
postoperative pain scores or complications10. These well-conducted studies show that restrictive 
opioid prescribing policies achieve the goal of reducing excess opioid exposure without 
causing undue harm, inconvenience or dissatisfaction amongst patients.  
Over 375,000 women undergo surgery for pelvic organ prolapse and urinary incontinence 
annually in the United States11. These patients represent a large population that are likely 
exposed to opioids in the postoperative period. In an effort to decrease excess opioid prescribing 
in the urogynecologic population, our section conducted a trial led by Dr. Davidson in which 
women undergoing prolapse surgery were randomized to standard (28 pill) versus reduced (5 
pill) opioid quantities, and found no difference in patient satisfaction12. Importantly, 37% of our 
study patients used no opioids at all after their operation. Similarly, Tolley et al. reported that 
42% of benign gynecologic patients exposed to a multimodal pain control regimen used no 
opioids after surgery13.  
 
Data from these studies support our belief that a restrictive opioid prescribing protocol, 
wherein patients are not prescribed opioids unless they request them, may be both feasible 
and acceptable to the urogynecologic patient population. To date, there has been no 
randomized controlled trial examining restrictive opioid prescribing practices after 
urogynecologic surgery. Our section has already instituted an enhanced recovery after surgery 
(ERAS) protocol in which multimodal analgesia is used on all surgical patients to maximize pain 
control and decrease opioid use. Furthermore, based off the results of the aforementioned study 
by Davidson et al, patients are discharged with a reduced opioid quantity of no more than 10 
tablets after prolapse surgery. We believe that physicians can capitalize on the new ability to 
electronically prescribe opioids for patients who require them after discharge to further 
prevent over-prescribing without impacting patient care.  
 
Hence, the objective of this study is to determine if a restrictive opioid prescription protocol (in 
which patients are not prescribed postoperative opioids unless they request them) is acceptable to 
patients after ambulatory and major urogynecologic surgery, compared to standard opioid 
prescribing practices. We also intend to describe postoperative opioid use patterns in the 
urogynecologic population, including factors predictive of opioid use and non-use. The results of 
this research will have a significant and timely impact by helping to reduce opioid 
overprescribing and informing future prescribing guidelines in the field of urogynecology. 
 
Specific Aims 
Aim 1. To compare patient satisfaction and pain control using two different opioid prescribing 
protocols. 

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We hypothesize that postoperative pain control and satisfaction will be non-inferior 
between patients not routinely prescribed opioids after surgery and those prescribed a 
standard quantity. Participants will be asked to rate their pain control during the first 7 
postoperative days with validated questionnaires. Participants’ satisfaction with pain 
control will be evaluated at their postoperative visit. 
Aim 2. To examine opioid use patterns after ambulatory and major urogynecologic surgery. 
We hypothesize that most postoperative patients will use few or no opioids after 
urogynecologic surgery, regardless of prescribing protocol. All participants will receive 
thorough counseling with detailed instructions on non-opioid pain management, as well 
as multimodal analgesia via ERAS protocol during the perioperative period. Participants 
will be asked to log their opioid and non-opioid medication use in the first postoperative 
week. We will also assess the number of requests for opioid prescription (in those 
randomized to the restrictive protocol) and opioid refills (from patients in the standard 
protocol).  
Aim 3. To determine patient and perioperative factors associated with opioid use after 
urogynecologic surgery. 
We plan to collect and analyze demographic, clinical and psychometric data on all 
participants with the goal of predicting analgesic needs and opioid use after 
urogynecologic surgery. Results from this study will guide surgeons on how to tailor 
opioid prescriptions to the needs of each patient, based off individual patient and 
perioperative characteristics. 
Research Plan 
1. Study Design 
This is a randomized controlled, non-inferiority trial evaluating pain control, satisfaction and 
opioid use after urogynecologic surgery under two opioid prescribing protocols. 
 
Arms and Interventions 
Control Arm: Standard postoperative medications (opioids and non-opioids) are prescribed 
upon discharge after surgery 
 
Intervention Arm: Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are 
prescribed upon discharge after surgery. Patients are allowed to request an opioid 
prescription if they so desire (see Study Intervention below).  
 
2. Outcome Measures 
Primary Outcome: Patient satisfaction with pain control at 6 week postoperative visit 
 
Secondary Outcomes:  
 Pain level scores during first postoperative week 
 Number of opioid pills used  
 Number of requests for new opioid prescription or refills 
 Predictive factors for opioid use after surgery 
 

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3. Study Population and Subject Identification 
Eligibility Criteria   
All patients of the Center for Urogynecology and Pelvic Reconstructive Surgery in the 
Department of Ob/Gyn and Women’s Health Institute at the Cleveland Clinic (Main Campus, 
Fairview Hospital, Hillcrest Hospital and Medina Hospital) scheduled to undergo surgery for 
pelvic organ prolapse and/or urinary incontinence* (see list below). 
 
Inclusion Criteria: 
 
Age >18 years old 
 
Access to ancillary care, including phone advice, nurse and outpatient clinic numbers  
 
Transportation to outpatient clinic or ability to access Virtual Care Visits 
 
Able to speak and read English 
 
Has decision-making capacity and able to provide consent for research participation 
 
Exclusion Criteria: 
 History of substance abuse disorder  
 Chronic opioid use 
 Score ≥ 30 on Pain Catastrophizing Scale14 [See Appendix 1] 
 Allergy (not intolerance) to ≥ 2 opioids 
 Contraindications to both NSAIDs and acetaminophen  
 Surgery scheduled before major federal holiday  
 Patients undergoing concomitant colorectal procedures  
 Patients with perioperative complication (e.g. iatrogenic bowel and bladder injury, 
hemorrhage, unanticipated laparotomy or ICU admission) 
 
* Surgical Procedures for pelvic organ prolapse and/or urinary incontinence included in 
this study: 
 Ambulatory Surgery: Isolated colporrhaphy (anterior, posterior) and perineorrhaphy; 
Placement of mid-urethral sling; Vaginal mesh removal or revision; Insertion of permanent 
neurostimulator for incontinence (InterStim) 
 
 Major Surgery: Vaginal vault suspension, Minimally invasive (laparoscopic or robotic-
assisted) sacrocolpopexy, Vaginal or minimally invasive hysteropexy (uterine suspension). 
 
Additional procedures accompanying the above major operations may include: hysterectomy 
(total or supracervical), trachelectomy, salpingectomy or salpingo-oophorectomy, anterior 
and/or posterior colporrhaphy with perineorrhaphy, enterocele repair, minimally invasive 
Burch colposuspension or paravaginal defect repair, vaginal mesh removal or revision, 
placement of vaginal graft, or placement of midurethral sling  
 
4. Study Procedures 
Randomization 
Trial participants will be randomized to one of two arms: 1) Standard Opioid Prescription 
(Control) or 2) Restrictive Opioid Prescription (Intervention). The allocation sequence will be 
generated with random block sizes using computer software. The assignment will be distributed 
to the primary surgeon using a sealed, opaque envelope. The primary surgeon is expected to 

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open the envelope and disclose the assignment to the patient on the day of surgery. If patients are 
assigned to the intervention arm, the sealed envelope will contain the randomization assignment 
as well as a brightly-colored sheet of paper without identifiers that is to be placed on the patient’s 
chart, indicating patient involvement in this research study, as well as a reminder to 
postoperative caregivers (i.e. nurses, residents).  
 
Study Paradigm  
Participant Screening and Consent 
Participants will be prospectively identified by the primary surgeon when the decision is made to 
proceed with ambulatory or major urogynecologic surgery. A chart review by the study 
investigators will be performed to ensure eligibility criteria is met. Patients will be contacted by 
telephone to introduce the study, explain the purpose of the study, risks, benefits and alternatives 
to participation using a phone script [See Appendix 6]. Patients who agree to participate will be 
approached by a study investigator or research nurse at their preoperative visit to sign a consent 
form and complete three questionnaires (Pain Catastrophizing Scale [PCS], Preoperative 
Questionnaire and Modified Pain Scales [See Appendices 1-3]). Encounter notes in the 
electronic medical record will document the screening phone call and informed consent process. 
Documentation including signing the consent form will be obtained at the preoperative visit. 
Please refer to the attached consent document for IRB review. 
 
Compensation will be provided to trial participants with a total of $50 in the form of two $20 
stipends (one mailed after the first postoperative week, the second after the patient attends their 
postoperative visit) and a $10 parking voucher, with the goals of increasing compliance in 
completing their logs, attending their 6 week postoperative visit, off-setting the cost of parking 
for that visit and minimizing patient drop out. Approval for funding of this research study to 
cover participant compensation, as well as personnel support, was granted by the Research 
Program Committees (RPC) and Women’s Health Institute on May 11, 2020 (RPC application 
#1785). 
 
Preoperative Visit   
Thorough preoperative surgical counseling will take place at the preoperative visit as per our 
standard protocol. The counseling will be performed by advanced practice providers or nursing 
staff, using a standardized template that includes discussion about normal postoperative 
symptoms and care, expected discharge pain medications and dosing regimen. Patients are 
instructed that they do not have to use an opioid prescription if it is not needed, per our usual 
practice. 
 
Other than the postoperative medications that patients are discharged home with, the 
perioperative pain control regimen will be the same for both study arms. The pain control 
regimen utilized involves a multimodal protocol [See Table 1] established after a prior study 
conducted in our department by Drs. Hickman and Paraiso.  
 
Day of Discharge 
Per protocol, all patients undergoing surgery will be prescribed a non-opioid pain relief regimen 
consisting of a 7-day supply of ibuprofen and acetaminophen at hospital discharge. Patients will 
be instructed to take both acetaminophen and ibuprofen around the clock for 3 days, then as 

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needed thereafter. Patients are instructed to “stagger” these medications, such that the patient 
will take a dose of either acetaminophen or ibuprofen every 3-4 hours to permit continuous 
analgesia.  
 
Study Intervention 
Control Arm: In addition to the above non-opioid regimen, patients randomized to the Standard 
Opioid Prescription arm will receive an opioid prescription for breakthrough pain upon 
discharge. Currently, it is our practice to discharge patients with a small opioid prescription of 5-
10 pills for major urogynecologic surgery and 2-5 pills for ambulatory surgery. Providers will be 
recommended to prescribe oxycodone 5 mg every 6 hours as needed, but substitutions for other 
opioids will be allowed based on surgeon discretion.  
 
Intervention Arm: Patients randomized to the Restrictive Opioid Prescription arm will be 
discharged with non-opioid prescriptions only. If the patient requests an opioid prescription on 
the day of discharge, the patient will be provided with a 1-day supply (4 pills). To ensure that 
postsurgical pain is well controlled after discharge, we will make clear that patients can 
request an opioid prescription or refill by telephone. All study participants will receive a 
scheduled telephone call by a caregiver on the day after discharge from the hospital (see below), 
and patients in the intervention arm will be asked if an opioid prescription needs to be called in. 
If a prescription is requested over telephone, the patient will be triaged by a nurse and physician. 
The opioid prescription will be electronically prescribed by the triaging physician, and a 
maximum of 10 opioid pills will be provided, per physician judgment and the level of surgery. If 
the physician deems that the patient’s pain is related to a postsurgical complication, the patient 
will be requested to come in for an urgent postoperative visit. Virtual Care Visits will be utilized 
if deemed appropriate.  
 
Contact information and instructions for postoperative questions/concerns will be given to all 
patients at discharge.  
 
Postoperative Period 
At the time of discharge, patient will be reminded to complete logs of their pain medication use 
and pain levels for the first 7 days. They will be given the option to do this electronically through 
Research Electronic Data Capture (REDCap) or by using paper forms. They will indicate their 
preference on the preoperative questionnaire. If they prefer the latter, these forms will be 
provided to them at discharge. 
 
All patients will be contacted by telephone on the day after discharge from the hospital by one of 
the study investigators. During the telephone call, the investigator will assess the patient’s 
postoperative pain control and elicit any questions or concerns about their pain medications. 
Other postoperative concerns will be promptly relayed to the patient’s surgical team. Study 
participants will be reminded to complete their pain medication and pain scale logs during their 
first telephone call and by text or email messages on postoperative days (POD) 3 and 7 [See 
Appendix 7]. Participants will be asked their preferred modality for reminder communications 
on the Preoperative Questionnaire. For patients who elect text message communication, the first 
text message will indicate that data rates may apply and the option to opt out of text messaging. 

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Subsequent text messages will contain a reminder and a link to their individualized REDCap 
logs. Similarly, email messages will contain a reminder and link to REDCap. 
 
All postoperative telephone calls to the surgeon’s office from study participants will be reviewed 
by individuals on the patient’s surgical team. If a patient calls due to inadequate postoperative 
pain control, and the physician believes that an adjunctive non-opioid medication (e.g. 
gabapentin, cyclobenzaprine) would be better for pain relief than an opioid prescription, they 
may prescribe this instead. If any patients require a second opioid prescription, office evaluation 
is required. 
 
The following postoperative assessments will be performed: 
 Pain Level: Patients will be asked to report their pain level for the first 7 days 
postoperatively. Pain levels will be assessed using questions 1, 2 and 4 from the Modified 
Surgical Pain Scales (SPS)15 [See Appendix 3], which measures pain at rest, during normal 
activities and quantifies unpleasantness of worst pain using an 11-point numeric rating score.  
 Medication Usage: Patients will be asked to log their daily non-opioid and opioid 
medication usage for the first 7 days postoperatively [See Appendix 4]. 
All patients will have a scheduled postoperative visit at 6 weeks. At this visit, any paper 
versions of the postoperative pain scales and medication logs will be collected. 
 Patient Satisfaction and Pain Expectations: Patient satisfaction with postoperative pain 
control and how pain expectations were met will be assessed with a 5-point Likert scale [See 
Appendix 5] at the postoperative visit. 
 
Table 2. Summary of Tasks for Study 
 
 
Preop 
DOS 
POD1 
POD2 
POD3 
POD4 
POD5 
POD6 
POD7 
6 wks 
Pain Catastr. 
Scale 
X 
 
 
 
 
 
 
 
 
 
Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
Demographic 
Data 
X 
 
 
 
 
 
 
 
 
 
Surgical Pain 
Scales 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Randomizatio
n 
 
X 
 
 
 
 
 
 
 
 
Pain Med 
Log 
 
 
X 
X 
X 
X 
X 
X 
X 
 
Patient 
Satisfaction 
 
 
 
 
 
 
 
 
 
X 
Pain 
Expectations 
 
 
 
 
 
 
 
 
 
X 
 
5. Statistical Plan 
Sample Size: 

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The primary outcome of this study is to compare patient satisfaction with postoperative pain 
control using two different opioid prescribing protocols. Power analysis is based on our prior 
study by Davidson et al. demonstrating 93% patient satisfaction with pain control with reduced 
(5 pills) opioid prescribing13.  
 
If there is truly no difference between the Standard and Restrictive Opioid Prescribing Protocols 
(93% patient satisfaction in both groups), a sample size of 122 is required to demonstrate with 
90% power that the upper limit of a one-sided 97.5% confidence interval will exclude a 
difference in favor of the standard group of more than 15% (non-inferiority margin). To allow 
for an anticipated 5% dropout rate, a total of 128 participants are required (64 per arm). 
 
Statistical Analysis:  
Continuous descriptive data will be reported as mean and standard deviation (±SD) or median 
with interquartile range (IQR), depending on distribution. Categorical data will be reported as 
frequencies, using percentages. Patient satisfaction, pain scores at each time point and overall 
opioid use will be compared between arms. The investigators also plan to perform two subgroup 
analyses, comparing these study outcome measures between ambulatory and major 
urogynecologic surgery patients, and secondly, comparing baseline and perioperative 
characteristics between opioid users and non-users.  
 
Patient satisfaction will be compared as a dichotomized variable using the chi-squared test. Pain 
scores will be treated as continuous, non-normally distributed data and will be compared using 
the Mann-Whitney U test. Opioid usage as a dichotomized variable will be compared using chi-
squared test. Opioid usage in MMEs will also be compared using student’s t-test. Binary logistic 
regression will be used to assess the influence of various patient and perioperative factors on the 
probability of using opioids, and results will be reported as odds ratios with 95% confidence 
intervals. JMP 14.0 (SAS Institute Inc., Cary, NC) will be used for all statistical analyses. The 
primary investigators (ASY, CAF) will perform the statistical analysis. 
 
All analyses will be conducted using an intention-to-treat principle. The investigators anticipate 
that some non-adherence to the assigned therapy (e.g. crossover to opioid use in the intervention 
arm) will occur, and as these protocol deviations will bias the results towards non-inferiority, a 
per-protocol sensitivity analysis has also been planned. 
 
All analyses, with the exception of that for our primary outcome, will be conducted with an a 
priori alpha level of 0.05; results yielding p < 0.05 are deemed statistically significant. For our 
primary outcome of demonstrating non-inferiority in patient satisfaction between arms, a one-
sided alpha of 0.025 will be used, as this is considered to be more robust for non-inferiority 
assessment; the confidence interval is wider and therefore more likely to cross the non-inferiority 
margin.  
 
6. Data Collection 
Preoperative data will include the following: 
 Pain Catastrophizing Scale score 
 Patient MRN, age, race, ethnicity, vaginal parity, menopausal state, current tobacco use, 
BMI, prior prolapse and anti-incontinence surgery, preoperative prolapse stage  

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 Preference for paper or electronic logs, Preference for text or email reminder 
communication and preferred mobile phone number or email address. 
 Modified Surgical Pain Scale scores 
 
Perioperative data will include the following: 
 Surgery date 
 Surgeon (de-identified) 
 Surgery level (Ambulatory, Major), surgery type, concomittant procedures 
 Operative time 
 Estimated blood loss 
 Intraoperative complications 
 Hospital length of stay  
 Voiding trial (Pass/Fail) 
 No. of opioid doses (IV and oral) postoperatively during admission 
 Total MMEs of opioids used postoperatively during admission  
 Did patient receive scheduled ketorolac and acetaminophen during admission? (Y/N) 
 Last pain score at time of discharge  
 Postoperative prescriptions at discharge and adherence to randomized assignment  
 
Postoperative data will include the following: 
 Daily Surgical Pain Scales 
 Daily pain medication logs for opioid and non-opioid medications  
 Telephone calls, urgent office visits and virtual visits for pain  
 Emergency department visits and hospital readmissions 
 Requests for opioid prescription or refills, Additional prescriptions for non-opioid 
(adjunctive) medications 
 Patient satisfaction and pain expectations 
 Postoperative complications  
 
7. Data Management Plan 
Protection of each subject’s personal health information will be a priority in this study. One 
master excel file containing subject personal information including name and medical record 
number will be kept in a password-protected file, on a designated protected research drive on a 
password-protected computer in a locked office at the Cleveland Clinic. In that file, each subject 
will be assigned a subject identification number that will be used for the purposes of data 
collection in order to de-identify subjects. All paper forms used for data collection will be kept in 
a research cabinet dedicated to this project which will be locked at all times, in a locked office at 
the Cleveland Clinic. All forms will contain de-identified information – identification numbers 
will correspond to the subjects listed in the master excel file. All study data will be transferred 
and managed electronically using REDCap. Each subject will be entered into REDCap using the 
assigned identification number from the master excel file.  
8. Adverse Events and Data Monitoring: 
Any adverse event or unanticipated events will be reported as soon as feasible to the IRB using 
IRB WebKit. Examples of adverse events include hospitalization or disability (substantial 
disruption of a person’s ability to conduct normal life functions) due to inadequate pain control. 

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All events will be recorded and kept in a research binder assigned to this study in a locked office. 
Monthly reviews during the study period will be done by all involved study staff members to 
ensure that events are not occurring, and if they are, that they are being handled and reported 
properly. The study will be terminated if over 50% of patients in the Restrictive Opioid 
Prescribing arm request more or stronger medication during interim analysis or have >20% 
decreased satisfaction to the control group; this will be assessed monthly at the reviews 
mentioned above.  
 
9. Timeline for Completion  
The goal for this research study is for completion by the conclusion of the primary investigator’s 
(ASY) three year fellowship at Cleveland Clinic (June 2022).  After obtaining institutional 
review board approval, a discussion will be held at our section research meeting to educate all 
urogynecology staff, fellows, and nurse practitioners on the implementation of this project. An 
in-service will be given to familiarize outpatient nursing staff with the project. Additionally, an 
email will be sent to the OB/GYN residents outlining key components of the project, and an in-
service will be given to the residents on our service.  
Patient recruitment will begin thereafter with the goal of recruiting and complete data collection 
on all patients over an 8 month time period.  At the end of this time, data analysis will be 
performed and manuscript preparation will be initiated. The manuscript will be submitted to a 
high impact gynecology journal at the end of the 12 month time period.  This timeline ensures 
project completion well before the conclusion of the primary investigator’s fellowship. 
References 
1. 
Centers for Disease Control and Prevention. 2019 Annual Surveillance Report of Drug-Related Risks and Outcomes — 
United States Surveillance Special Report. Centers for Disease Control and Prevention, U.S. Department of Health and 
Human Services. Published November 1, 2019. Accessed 3/6/2020 from https://www. cdc.gov/drugoverdose/pdf/ 
pubs/2019-cdc-drug-surveillancereport.pdf.  
2. 
Shadbolt C, Abbott JH, Camacho X, et al. The Surgeon's Role in the Opioid Crisis: A Narrative Review and Call to Action. 
Front Surg. 2020 Feb 18;7:4. 
3. 
Levy B, Paulozzi L, Mack KA, et al. Trends in opioid analgesic-prescribing rates by specialty, US, 2007-2012. Am J Prev 
Med2015;359:409-13.  
4. 
Hill MV, McMahon ML, Stucke RS, et al. Wide variation and excessive dosage of opioid prescriptions for common general 
surgical procedures. Ann Surg 2017;265:709-714. 
5. 
Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids 
Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859.  
6. 
Patanwala I, Ouyang C, Fisk M, et al. Opioid Prescription Usage after Benign Gynecologic Surgery: A Prospective Cohort 
Study. J Minim Invasive Gynecol. 2019 Jul 15. 
7. 
Movilla PR, Kokroko JA, Kotlyar AG, et al. Postoperative Opioid Use Using Enhanced Recovery After Surgery Guidelines 
for Benign Gynecologic Procedures. J Minim Invasive Gynecol. 2020 Feb;27(2):510-517. 
8. 
Overton HN, Hanna MN, Bruhn WE, et al. Opioid-Prescribing Guidelines for Common Surgical Procedures: An Expert 
Panel Consensus. J Am Coll Surg. 2018 Oct;227(4):411-418. 
9. 
Hallway A, Vu J, Lee J, et al. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am 
Coll Surg. 2019 Sep;229(3):316-322. 
10. Mark J, Argentieri DM, Gutierrez CA, et al. Ultrarestrictive Opioid Prescription Protocol for Pain Management After 
Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. 
11. Wu JM, Kawasaki A, Hundley AF, et al. Predicting the number of women who will undergo incontinence and prolapse 
surgery, 2010 to 2050. Am J Obstet Gynecol. 2011 Sep;205(3):230.e1-5. 
12. Davidson ERW, Paraiso MFR, Walters MD, et al. A Randomized Controlled Non-Inferiority Trial of Reduced Versus 
Routine Opioid Prescription after Prolapse Repair. Am J Obstet Gynecol. 2020 Mar [Article in Press]. 
13. Tolley C, MacAfee L, Cantillo E, et al. 2524 Perioperative Non-Opioid Pain Control Adjuncts and Postoperative Opioid Use 
after Benign Gynecologic Surgery [Abstract]. J Minim Invasive Gynecol. 2019 Nov-Dec;26(7):S136. 
14. Sullivan MJL, Bishop S, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 432-
524. 

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Barber, MD, Janz, N, Kenton K, et al. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. 
Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. 
Table 1. Multimodal Pain Control Regimen 
 
Preoperative 
• 
Acetaminophen: 1000 mg orally, once 
• 
Celecoxib: 200 mg orally, once 
• 
Gabapentin: 600 mg (or 300 mg if age > 65 years or <50 kg) orally, once 
Intraoperative 
• 
Use of intradermal analgesia at surgeon discretion 
• 
Ketorolac 15 mg intravenously at the conclusion of the surgical procedure 
Postoperative, in hospital 
• 
Scheduled acetaminophen: 1000 mg orally every6 h 
• 
Scheduled non-steroidal anti-inflammatory: 
o 
Ketorolac 30 mg (or 15 mg if age > 65 years or <50 kg) intravenously every 6 h for  4 doses  
o 
Ibuprofen 600 mg orally every 6 h (start 6 h after last dose of ketorolac) 
• 
Oral opioids: 
o 
Oxycodone 
 
5 mg orally every 6 h as needed for moderate pain (pain 4–6/10) 
 
10 mg orally every 6 h as needed for severe pain (pain 7–10/10) 
o 
If oxycodone not tolerated, oral tramadol: 
 
50 mg orally every 6 h as needed for moderate pain (pain 4–6/10) 
 
100 mg orally every 6 h as needed for severe pain (pain 7–10/10) 
• 
Ice pack or cold gel pack: Apply to vulva and perineum q 2 h for 20 mins around the clock until discharge 
Postoperative, post-discharge 
• 
Scheduled acetaminophen: 1000 mg orally every 6 h for 3 days, then as needed for pain, 21 pills 
• 
Scheduled ibuprofen: 600 mg orally every 6 h for 3 days, then as needed for pain, 28 pills 
• 
Oral opioids, if randomized to Standard Opioid Prescribing arm 
o 
Oxycodone 5 mg (or tramadol 50 mg, if oxycodone not tolerated) every 6 hours as needed for 
breakthrough pain not controlled by non-opioid medications 
 
If major urogynecologic surgery: 5 to 10 pills 
 
If ambulatory urogynecologic surgery: 2 to 5 pills