ICET: Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03052816
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Pelvic Organ Prolapse	Drug: Ice T; Drug: Motrin/Percocet/Dilaudid for breakthrough	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Jun 1, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scores (VAS) [Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.]

   Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.

Secondary Outcome Measures

1. VAS Scores at 4 Hours Post Surgery [VAS Scores at 4 hours post surgery]

   VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.

2. VAS Scores 96 Hours After Surgery [VAS Scores 96 hours after surgery]

   VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.

3. Quality of Recovery Scores on Post op Day 1 [Quality of Recovery scores on post op day 1]

   Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.

4. Satisfaction Scores in the Morning After Surgery (7AM) [Satisfaction scores in the morning after surgery (7AM)]

   Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.

5. Satisfaction Scores 96 Hours After Surgery [Satisfaction scores 96 hours after surgery]

   Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.

6. Length of Stay [Time from end of surgery to discharge home from hospital, assessed up to 1 week.]

   Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.

7. Total Dose of Opioids Administered During Hospitalization [Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week]

   Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.

8. Postoperative Nausea and Vomiting at 7AM After Surgery [Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery]

   Number of patients with postoperative nausea and vomiting at 7AM after surgery

9. Number of Participants With Urinary Retention. [Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.]

   Number of participants with urinary retention (discharge home with foley)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

• 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

• 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

Exclusion Criteria:

• The exclusion criteria are the following:

• History of chronic pelvic pain

• Abdominal surgery

• Laparoscopic surgery

• History of psychiatric disease

• Currently taking analgesic medications

• Currently taking sedatives

• Liver disease

• Renal disease with CrCl < 60cc/min.

• 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

• Active or history of peptic ulcer disease

• History of GI bleeding or perforation

• Hemorrhagic diathesis

• Severe uncontrolled heart failure

• Inflammatory bowel disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 9, 2016

More Information

Publications

None provided.

• Responsible Party: Andrey Petrikovets, Physician, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT03052816
• Other Study ID Numbers: 16-00498
• First Posted: Feb 14, 2017
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pain, Postoperative; Pelvic Organ Prolapse; Hydromorphone

Study Results

Participant Flow

Recruitment Details

Study approved January 30th, 2017. First patient recruited April 2017. Between April 2017 and April 2018, 138 women who were scheduled for surgery were assessed. 72 patients were excluded. Sixty-six patients were randomized to the ICE-T or Standard protocols. Of the 33 patients who were randomized to the ICE-T regimen, three were excluded after randomization. Ultimately, thirty patients in the ICE-T arm and 33 patients in the Standard arm were analyzed.

Pre-assignment Detail

138 Patients assessed for eligibility. 72 patients excluded: 55 not meeting inclusion criteria and 17 declined to participate. 66 were randomized.

Arm/Group Title	ICE T Postoperative Pain Regimen	Standard Postoperative Pain Regimen
Arm/Group Description	ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with PO Tylenol and PO toradol PRN. Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough	Motrin 600mg PO Q4h PRN pain 1-3 Percocet 1 tab PO Q4-6 hours PRN 4-6 pain Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN. Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
Period Title: Overall Study
STARTED	33	33
COMPLETED	30	33
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	ICE T	STANDARD	Total
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16	Total of all reporting groups
Overall Participants	30	33	63
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	20 66.7%	21 63.6%	41 65.1%
>=65 years	10 33.3%	12 36.4%	22 34.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.8 (10.1)	59.8 (12.7)	60.7 (11.4)
Sex: Female, Male (Count of Participants)
Female	30 100%	33 100%	63 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 23.3%	5 15.2%	12 19%
White	20 66.7%	28 84.8%	48 76.2%
More than one race	3 10%	0 0%	3 4.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	30 100%	33 100%	63 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scores (VAS)
Description	Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Time Frame	Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	Standard
Arm/Group Description	ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with PO Tylenol and PO toradol PRN. Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough	Motrin 600mg PO Q4h PRN pain 1-3 Percocet 1 tab PO Q4-6 hours PRN 4-6 pain Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN. Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
Measure Participants	30	33
Median (Inter-Quartile Range) [mm]	20	40

2. Secondary Outcome

Title	VAS Scores at 4 Hours Post Surgery
Description	VAS Scores at 4 hours post surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Time Frame	VAS Scores at 4 hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	Standard
Arm/Group Description	ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with PO Tylenol and PO toradol PRN. Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough	Motrin 600mg PO Q4h PRN pain 1-3 Percocet 1 tab PO Q4-6 hours PRN 4-6 pain Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN. Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
Measure Participants	30	33
Median (Inter-Quartile Range) [mm]	35	50

3. Secondary Outcome

Title	VAS Scores 96 Hours After Surgery
Description	VAS Scores 96 hours after surgery. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.
Time Frame	VAS Scores 96 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Median (Inter-Quartile Range) [mm]	20	30

4. Secondary Outcome

Title	Quality of Recovery Scores on Post op Day 1
Description	Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.
Time Frame	Quality of Recovery scores on post op day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Median (Inter-Quartile Range) [score on a scale]	182	173

5. Secondary Outcome

Title	Satisfaction Scores in the Morning After Surgery (7AM)
Description	Satisfaction scores in the morning after surgery (7AM). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Time Frame	Satisfaction scores in the morning after surgery (7AM)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Median (Inter-Quartile Range) [score on a scale]	10	10

6. Secondary Outcome

Title	Satisfaction Scores 96 Hours After Surgery
Description	Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.
Time Frame	Satisfaction scores 96 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Median (Inter-Quartile Range) [score on a scale]	10	9

7. Secondary Outcome

Title	Length of Stay
Description	Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.
Time Frame	Time from end of surgery to discharge home from hospital, assessed up to 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Mean (Standard Deviation) [hours]	24.1 (3.1)	24.1 (5.4)

8. Secondary Outcome

Title	Total Dose of Opioids Administered During Hospitalization
Description	Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.
Time Frame	Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Mean (Standard Deviation) [milligrams of oral morphine equivalents]	55.7 (31.2)	91.2 (38.9)

9. Secondary Outcome

Title	Postoperative Nausea and Vomiting at 7AM After Surgery
Description	Number of patients with postoperative nausea and vomiting at 7AM after surgery
Time Frame	Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Count of Participants [Participants]	14 46.7%	18 54.5%

10. Secondary Outcome

Title	Number of Participants With Urinary Retention.
Description	Number of participants with urinary retention (discharge home with foley)
Time Frame	Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ICE T	STANDARD
Arm/Group Description	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: ICE PACKS applied to the perineum Q2h for 20 minutes ATC until discharge Ketorolac 30mg IV Q6h ATC until discharge Acetaminophen 1g PO Q6h ATC until discharge Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Acetaminophen 1 gram PO every 6 hours PRN pain 1-5 #60 Ketorolac 10mg PO every 6 hours PRN pain #6-10 #16	• At the end of surgery patients receive 30mg of IV ketorolac. Once out of PACU patients receive: Ibuprofen 600mg PO Q4h PRN pain 1-3 Acetaminophen/oxycodone 5mg/325mg 1 tablet PO Q4-6h PRN pain 4-6 Acetaminophen/oxycodone 5mg/325mg 2 tablets PO Q4-6h PRN pain 7-10 Hydromorphone 0.2mg IV Q3h PRN for breakthrough pain Patients are discharged home with: Ibuprofen 600mg PO Q8h PRN pain 1-5 #60 Acetaminophen/oxycodone 5mg/325mg 1-2 tablets Q4-6h PRN pain 6-10 #16
Measure Participants	30	33
Count of Participants [Participants]	5 16.7%	7 21.2%

Adverse Events

Time Frame	Each patient was assessed for adverse events during the course of the entire study extending one month after completion of recruitment to allow for one month after surgery for each patient recruited.
Adverse Event Reporting Description	An independent data and safety monitoring physician in the Department of Obstetrics and Gynecology at both institutions oversaw the progress of the study.
Arm/Group Title	ICE T		Standard
Arm/Group Description	ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with PO Tylenol and PO toradol PRN. Ice T: Ice/Tylenol/Toradol with dilaudid for breakthrough		Motrin 600mg PO Q4h PRN pain 1-3 Percocet 1 tab PO Q4-6 hours PRN 4-6 pain Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN. Motrin/Percocet/Dilaudid for breakthrough: Standard regimen
All Cause Mortality
	ICE T		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/33 (0%)
Serious Adverse Events
	ICE T		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	ICE T		Standard
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.