ICE T for Post GYN Surgery Pain

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial is to determine whether, ICE-T, a multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control compared to the standard narcotic based postoperative pain regimen in patients undergoing total laparoscopic gyn surgery.

Official Title
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ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial

Conditions
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Opioid Substitution Treatment

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Opioids
* Other: Ice Packs
* Drug: Tylenol
* Drug: Motrin
* Drug: dilaudid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria are the following: Consenting, English speaking women between ages 18 and 80 who will undergo same day laparoscopic gyn surgery at MetroHealth Medical Center Ability to read VAS Scores Specific procedures include, but are not limited to: Laparoscopic hysterectomy, for uterus 250 g or less Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s) Laparoscopic hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele Laparoscopic hysterectomy, for uterus 250 g or less; with repair of enterocele Laparoscopic hysterectomy, for uterus greater than 250 g Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s) Laparoscopic hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele Laparoscopic hysterectomy, for uterus greater than 250 g; with repair of enterocele Exclusion Criteria: History of chronic pelvic pain Abdominal 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICE-T<br>Regimen #1 ICE-T Opioid Sparing Regimen At the end of surgery patients will receive 30mg of intravenous (IV) toradol. Once out of the post anesthesia care unit (PACU) patients will receive ICE PACKS applied to the surgical sites every hour for 20 minutes Around the clock (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 per os (PO) every 6 hours for a total of 4 grams daily ATC until discharge Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). | Drug: Ketorolac<br>* Use of non-steroidal anti-inflammatory drug for pain control post operatively<br>* Other names: Toradol;Other: Ice Packs<br>* Placement of Ice packs on surgical sites post operatively<br>Drug: Tylenol<br>* Use of pain medication post operatively<br>Drug: dilaudid<br>* Use of narcotic for pain control post operatively<br>|
| Active Comparator: Standard of care<br>Regimen #2 STANDARD Postoperative Regimen Once out of the PACU patients will receive Standard postoperative regimen Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. Patients will be discharged home with Motrin and Percocet for pain PRN. | Drug: Opioids<br>* Use of narcotic for pain control post operatively<br>* Other names: Oxycodone;Drug: Motrin<br>* Use of non-steroidal anti-inflammatory drug for pain control post operatively<br>Drug: dilaudid<br>* Use of narcotic for pain control post operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain (VAS) score | Visual Analog Scores (VAS) Scores in the morning of post op day 1 ( 24 hours after surgery) The scale is from 0 to 10 (0=no pain and 10=being worst pain ever) | Morning of post operative day 1 ( 24 hours after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Scores | Visual Analog Scores at 4 and 12 hours post surgery. The scale is from 0 to 10 (0=no pain and 10=being worst pain ever) | VAS Scores at 4 and 12 hours post surgery | 
| Length of stay | Length of hospital stay in number of days | Total length of hospitalization in days | 
| Total dose of opioid | Total amount of opioids in morphine equivalents | Total opioid use up to post op day 4 | 
| Incidence of urinary retention | Incidence of urinary retention | Up to post op day 4 | 
| Time to first bowel movement | Time to first bowel movement in days | Up to post op day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-inflammatory agents non-steroidal