Clinical trial NCT03052816
Conditions: Pain, Postoperative Pelvic Organ Prolapse
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2017-04-01; Completion date: 2018-06-30
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

Detailed description:
Pelvic floor disorders involve a myriad of complicated, interwoven clinical conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, and other pathology involving the genital and lower urinary tract. It is estimated that pelvic floor disorders affect up to 25% of all adult women in the United States with increasing prevalence with age. By the age of sixty, 1 in 9 women will undergo surgical intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age of 80. As the population in the United States ages, the demand for healthcare for pelvic floor disorders is estimated to increase up to 40% in the next 30 years.

Despite the prevalence of surgery performed for pelvic floor disorders, there is a paucity of data on postoperative pain control that is dedicated to female pelvic reconstructive surgery. In a recent review, there was only one study that evaluated postoperative pain control after vaginal reconstructive surgery, and the mainstay of therapy was opioid driven. Generally, postoperative pain control in gynecologic surgery has been opioid driven, frequently involving multiple narcotics for analgesia, resulting opioid related complications, including nausea, vomiting, constipation, urinary retention, and central nervous system side effects In an effort to combat opioid use in gynecologic and female pelvic reconstructive surgery, multimodal therapy has been gaining momentum with goals of improved pain control and decreased opioid requirements. Ice packs, toradol, and acetaminophen have been used in various trials to decrease postoperative opioid requirements in various surgeries.

Ice packs have been shown to be effective in the treatment of postoperative pain after abdominal midline incisions. A Cochrane Review of patients subject to post vaginal delivery perineal cooling included 10 randomized controlled trials with1825 patients with some evidence that local cooling in the form of ice packs, cold gel packs, cold/ice backs may be effective in pain relief.

Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic. It has been administered preemptively, intraoperatively, and postoperatively for pain control with evidence that toradol decreases postoperative subjective pain scores and decreased narcotic use.

Acetaminophen is mainstay for postoperative pain control as part of multimodal pain regimens to complement other, opioid sparing medications in a multitude of surgeries including abdominal hysterectomy.

Therefore, the purpose of this randomized controlled study is to determine whether, "ICE-T" a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control and decrease opioid intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

Arms: arm 1: 1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with PO Tylenol and PO toradol PRN. arm 2: 1. Motrin 600mg PO Q4h PRN pain 1-3
2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
5. Patients will be discharged home with Motrin and Percocet for pain PRN.
Interventions: intervention 1: Ice T intervention 2: Motrin/Percocet/Dilaudid for breakthrough
Intervention descriptions: intervention 1: Ice/Tylenol/Toradol with dilaudid for breakthrough intervention 2: Standard regimen

Protocol documents:
Prot_SAP_002.pdf: 
 
1 
 
 
 
 
 
COVER PAGE 
 
 
 
TITLE:  ICE-T postoperative multimodal pain regimen compared to the standard 
regimen in vaginal pelvic reconstructive surgery: a randomized controlled trial 
 
DOCUMENT DATE: September 9, 2016  
 
NCT03052816 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
2 
 
ICE-T Randomized Controlled Trial 
 
TITLE:  ICE-T postoperative multimodal pain regimen compared to the standard 
regimen in vaginal pelvic reconstructive surgery: a randomized controlled trial 
 
BACKGROUND: 
 
 
Pelvic floor disorders involve a myriad of complicated, interwoven clinical 
conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, 
and other pathology involving the genital and lower urinary tract. It is estimated that 
pelvic floor disorders affect up to 25% of all adult women in the United States with 
increasing prevalence with age 1,2 By the age of sixty, 1 in 9 women will undergo surgical 
intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age 
of 80.3 As the population in the United States ages, the demand for healthcare for pelvic 
floor disorders is estimated to increase up to 40% in the next 30 years. 4,5 
 
Despite the prevalence of surgery performed for pelvic floor disorders, there is a 
paucity of data on postoperative pain control that is dedicated to female pelvic 
reconstructive surgery.  In a recent review, there was only one study that evaluated 
postoperative pain control after vaginal reconstructive surgery, and the mainstay of 
therapy was opioid driven. 6,7  Generally, postoperative pain control in gynecologic 
surgery has been opioid driven, frequently involving multiple narcotics for analgesia, 
resulting opioid related complications, including nausea, vomiting, constipation, urinary 
retention, and central nervous system side effects. 6 
 
In an effort to combat opioid use in gynecologic and female pelvic reconstructive 
surgery, multimodal therapy has been gaining momentum with goals of improved pain 
control and decreased opioid requirements. 8,9  Ice packs, toradol, and acetaminophen 
have been used in various trials to decrease postoperative opioid requirements in various 
surgeries. 
 Ice packs have been shown to be effective in the treatment of postoperative pain 
after abdominal midline incisions. 10A Cochrane Review of patients subject to post 
vaginal delivery perineal cooling included 10 randomized controlled trials with1825 
patients with some evidence that local cooling in the form of ice packs, cold gel packs, 
cold/ice backs may be effective in pain relief.   11 
 
Toradol has been extensively studied in a multitude of surgeries including spinal, 
obstetric, orthopedic, urologic, and gynecologic.  It has been administered preemptively, 
intraoperatively, and postoperatively for pain control with evidence that toradol decreases 
postoperative subjective pain scores and decreased narcotic use. 12-14  
Acetaminophen is mainstay for postoperative pain control as part of multimodal 
pain regimens to complement other, opioid sparing medications in a multitude of 
surgeries including abdominal hysterectomy. 15 
 
Therefore, the purpose of this randomized controlled study is to determine 
whether, “ICE-T” a novel multimodal postoperative pain regimen composed of around 
the clock ice packs, toradol, and tylenol, l has improved pain control and decrease opioid 
intake compared to the standard postoperative pain regimen in patients undergoing 
vaginal pelvic floor reconstructive surgery. 


 
3 
 
HYPOTHESIS: “ICE-T” (around the clock Ice packs, toradol, tylenol) postoperative 
pain management protocol leads to improved patient perception of pain compared to the 
standard post operative pain regimen (primary outcome) 
 
QUESTION:  Does the ICE-T postoperative pain management protocol lead to 
improved patient perception of pain compared to the standard post operative pain 
regimen? 
 
DESIGN:  Randomized Control Trial. 
 
SETTINGS: Academic Institution. 
 
 
EXPERIMENTAL DESIGN AND METHODS: 
 
IRB approval will be obtained at MetroHealth Medical Center and University Hospitals 
Cleveland Medical Center 
This will be a randomized controlled trial that will be conducted at MetroHealth Medical 
Center and University Hospitals Cleveland Medical Center.  Preoperative written 
consents explicitly explaining the risks and benefits of the study will be obtained from the 
patients.  
 
The inclusion criteria are the following: 
 
-Consenting, English speaking women between ages 18 and 80 who will undergo same 
day vaginal female pelvic reconstructive surgery at MetroHealth Medical Center and 
University Hospitals Cleveland Medical Center 
-Ability to read VAS Scores 
 
-Specific vaginal procedures include, but are not limited to: 
 
§ Periurethral bulking 
§ Perineoplasty 
§ Complete vaginectomy 
§ Le Forte colpocleisis 
§ Anterior repair  
§ Posterior repair  
§ Enterocele repair  
§ Anterior and posterior repair 
§ Anterior, posterior and enterocele repair  
§ Transvaginal mesh use  
§ Sacrospinous ligament fixation  
§ Uterosacral ligament suspension  
§ Vaginal paravaginal defect repair 
§ Midurethral Sling 


 
4 
§ Sphincteroplasty 
§ Vaginal hysterectomy, for uterus 250 g or less 
§ Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or 
ovary(s)  
§ Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or 
ovary(s), with repair of enterocele 
§ Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele 
§ Vaginal hysterectomy, for uterus greater than 250 g 
§ Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) 
and/or ovary(s) 
§ Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) 
and/or ovary(s), with repair of enterocele 
§ Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele 
 
The exclusion criteria are the following: 
 
-History of chronic pelvic pain 
-History of psychiatric disease 
-Currently taking analgesic medications 
-Currently taking sedatives 
-Liver disease 
-Renal disease 
-History of burns from application of ice. 
-Women who did not consent for the study.  
-Intraoperative concern for increased blood loss 
-Unable to speak English 
-Unable to understand VAS Scores 
-Undergoing concomitant abdominal or laparoscopic procedures 
-Allergy to motrin, toradol, Percocet, Tylenol. 
-Planned abdominal or laparoscopic procedures. 
 
Demographic factors are recorded including, age, BMI, ethnicity, preoperative 
diagnosis, surgery performed. 
 
Once patients are selected and consents are obtained, they are randomized into the active 
and control group using computer generated randomization with sequentially numbered 
opaque sealed envelopes. 
 
Intraoperatively, duration of anesthesia, duration of surgery, estimated blood loss, 
intraoperative medications are recorded for each type of surgery.   
 
Depending on what postoperative regimen patients will be randomized to they will be 
given one of the following after surgery: 
 
Regimen #1 “ICE-T” Opioid Sparing Regimen 
 


 
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At the end of surgery patients will receive 30mg of IV toradol. 
Once out of the PACU patients will receive 
1.  ICE PACKS applied to the perineum every two hours for 20 minutes around the clock 
(ATC) until discharge. 
2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol 
ATC until discharge. The total daily dose of toradol administered is 120mg. Patients will 
be instructed not to take toradol for more than 5 days total.  
3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 
grams daily ATC until discharge 
4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 
5. Patients will be discharged home with 
 
A. Twenty tablets of Toradol 10mg PO every 6 hours PRN pain. Not to exceed 40 
milligrams daily. Patients are informed not take Toradol for more than 5 days total (this 
included in patient toradol administration.  
 
B. Sixty tablets of Tylenol 1000mg PO every 6 hours PRN pain. Not to exceed 4 
grams daily.  
 
C. Patients may continue ice packs at home at their leisure for 20 minutes every 2 
hours as needed. 
 
Regimen #2 STANDARD Postoperative Regimen 
 
1.  Once out of the PACU patients will receive “Standard” postoperative regimen 
2. Motrin 600mg PO Q4h PRN pain 1-3 
3. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain 
4. Percocet 2 tabs PO Q 4-6 hours PRN 7-10 pain 
5. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 
6. Patients will be discharged home with: 
 
A. 60 tablets of 600mg of motrin PO every 6 hours PRN Pain 
 
B. 20 tablets of Percocet PO every 6 hours PRN Pain.  
 
The medicine will be provided by the nursing staff as per pharmacy orders that patients 
are randomized to, regimen #1 or regimen #2.  
 
Patients will be provided prescriptions for medications they are discharged home with. 
 
The patients insurance is responsible for the medications. 
 
SAMPLE SIZE: 
 
 
     27 patients in each arm would be needed to achieve 90% power to detect a mean 
difference of ~25 mm on a 100mm VAS scale for a significance level of 0.05.  We will 
add 20% to account for loss to follow up and we will need 66 patients, 33 in each arm. 
This difference was selected based on multiple previous articles stating that a pain score 
difference between 20 and 30 is significant for most patients that perceived this as a 
moderate improvement in their pain after various types of surgery including head and 


 
6 
neck, thoracic, abdominal orthopedic, and spinal. This sample size is in concordance with 
the sample size of 27 patients in each arm used by Crisp, a urogynecologist, evaluating 
PCA vs. nurse administered analgesia after vaginal reconstructive surgery patients to 
determine a significant difference in VAS scores. 
 
    30 patients will be recruited at University Hospitals Cleveland Medical Center and a 
total of 66 patients will be recruited for this study. 
 
OUTCOMES: 
 
PRIMARY OUTCOMES: Visual Analog Scores (VAS) Scores at 7am after surgery 
 
SECONDARY OUTCOMES: 
-VAS Scores at PACU exit 
-Numerical Pain Scores Scores 96 hours after surgery 
-Quality of Recovery scores on post op day 1 (7AM)  
-Satisfaction scores in the morning after surgery (7AM) 
-Satisfaction scores 96 hours after surgery 
-Length of stay 
-Hemoglobin difference preop/postop 
-Total dose of opioids administered during hospitalization in oral morphine equivalents. 
-Postoperative nausea and vomiting with 24 hours of surgery, dizziness, headache, blurry 
vision, pruritus, drowsiness within 24 hours after surgery,  
-Time to first void 
-Incidence of urinary retention (discharge home with foley) 
-Time to first bowel movement (patients will ask to record this and there will be follow 
up via phone call 96 hours after surgery). 
 
Statistical analysis will be performed using statistical software, GraphPad. Continuous 
variables will be analyzed using the t-test/Mann-Whitney test and categorical variables 
will be analyzed using Chi-Square methods. 
 
 
 
. 
 
 
 
 
 
 
 
 
 
 
 


 
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REFERENCES: 
                                                        
1. Wu JM, Hundley AF, Fulton RG, et al. Forecasting the prevalence of pelvic floor 
disorders in U.S. women: 2010 to 205. Obstet Gynecol 2009; 114: 1278-1283. 
 
2. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor 
disorders in US women. JAMA 2008; 300:1311-1316. 
 
3. Wu JM, Matthews CA, Conover MM, et al. Lifetime risk of stress urinary incontinence 
or pelvic organ prolapse surgery. Obstet Gynecol 2014; 123: 12-1-1206. 
 
4. Kirby A, Luber KM, Menefee SA. An update on the current and future demand for 
care of pelvic floor disorders in the United States. Am J Obstet Gynecol 2013; 209:584 el-
584. E5. 
 
5.  Vincent GK. The Next Four Decades, the Older Population in the United States: 2010 
to 2050. Washington, DC: US Census Bureau, 2010. 
 
6. Collins SA, Quiroz LH, Steinberg AC, et al. Pain management strategies for 
urogynecologic surgery: A review. Female Pelvic Med Reconstr Surg 2014; 20:310-315. 
 
7. Crisp CC, Bandi S, Kleeman SD, et al. Patient-controlled versus scheduled, nurse-
administered analgesia following vaginal reconstructive surgery: a randomized trial. Am J 
Obstet Gynecol 2012;207(5):433.e431- e436. 
 
8.  Costello MF, Abbott J, Katz S, et al. A prospective, randomized, double-blind, 
placebo-controlled trial of multimodal intraoperative analgesia for laparoscopic excision 
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9.  Xiromeritis P, Kalogiannidis I, Papadopoulos E, et al. Improved recovery using 
multimodal perioperative analgesia in minimally invasive myomectomy: a randomized 
study. Aust N Z J Obstet Gynaecol 2011;51(4):301-306. 
 
10.  Watkins AA, Johnson TV, Shresberry AB, et al. Ice packs reduce postoperative 
midline incision pain and narcotic use: a randomized controlled trial. J Am Coll Surg 
2014; 219: 511e 517. 
 
11.  East CE, Begg L, Henshall NE, Marchant PR, Wallace K. Local cooling for relieving 
pain from perineal trauma sustained during childbirth. Cochrane Database of Systematic 
Reviews 2012, Issue 5. Art. No.: CD006304. DOI: 10.1002/14651858.CD006304.pub3. 
 
12.  De Oliveira GS, Agarwal D, Benzon HT. Perioperative single dose ketorolac to 
prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg 2012; 
114:424-33. 
 


 
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13.  Cassinelli EZ, Dean CL, Garcia RM, et al. Ketorolac use for postoperative pain 
management following lumbar decompression surgery. Spine 2008; 33: 1313-1317. 
 
14.  Lowder JL, Shackelford DP, Holbert D, et al. A randomized, controlled trial to 
compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and 
narcotic usage. Am J Obstet Gynecol 2003; 189: 1559-62. 
 
15.  Gilron I, Tu D, Dumerton-Shore D, et al.  The effect of tripe vs. double nonopioid 
therapy on postoperative pain and functional outcome after abdominal hysterectomy. Eu 
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