"ICE-T" Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ketorolac
- Conditions
- Opioid Substitution Treatment
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- POD1 Visual Analog Pain (VAS) Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Laparoscopy is a frequently used route for hysterectomy. Yet few studies have investigated opioid-sparing postoperative regimens for this common surgery. The study objective was to determine whether ice packs, Tylenol, and Toradol (ICE-T), an opioid-sparing multimodal postoperative pain regimen, has improved pain control compared with a standard opioid-centric postoperative pain regimen in total laparoscopic hysterectomy patients. The study was a randomized controlled trial. It included total laparoscopic hysterectomy postoperative patients that were randomized to the ICE-T or standard regimen. The ICE-T regimen prescribed scheduled around-the-clock ice-packs, acetaminophen and ketorolac. The standard protocol prescribed as needed ibuprofen and acetaminophen/oxycodone based on pain score. Both regimens included intravenous hydromorphone for breakthrough pain. However, subjects in the ICE-T group who requested additional narcotic medications prior to postoperative day 4, were prescribed supplemental narcotics in addition to the ICE-T regimen. The subjects pain control and quality of recovery were assessed on postoperative day 1 and 4.
Investigators
Robert Pollard, MD
Associate Professor of Reproductive Biology
MetroHealth Medical Center
Eligibility Criteria
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)
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
Arms & Interventions
"ICE-T"
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 1. ICE PACKS applied to the surgical sites every hour 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. 3. 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 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
Intervention: Ketorolac
"ICE-T"
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 1. ICE PACKS applied to the surgical sites every hour 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. 3. 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 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
Intervention: Opioids
"ICE-T"
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 1. ICE PACKS applied to the surgical sites every hour 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. 3. 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 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
Intervention: Ice Packs
"ICE-T"
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 1. ICE PACKS applied to the surgical sites every hour 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. 3. 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 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
Intervention: Tylenol
"ICE-T"
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 1. ICE PACKS applied to the surgical sites every hour 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. 3. 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 4. Patients will receive dilaudid 0.2mg IV every 3 hours as needed (PRN) for breakthrough pain. 5. Patients will be discharged home with (PO) Tylenol and PO toradol as needed (PRN). 6. If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control
Intervention: Dilaudid Injectable Product
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen 1. Once out of the PACU patients will receive "Standard" postoperative regimen 2. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 3. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 4. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 5. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 6. Patients will be discharged home with Motrin and Percocet for pain PRN.
Intervention: Opioids
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen 1. Once out of the PACU patients will receive "Standard" postoperative regimen 2. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 3. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 4. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 5. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 6. Patients will be discharged home with Motrin and Percocet for pain PRN.
Intervention: Motrin
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen 1. Once out of the PACU patients will receive "Standard" postoperative regimen 2. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 3. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 4. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 5. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 6. Patients will be discharged home with Motrin and Percocet for pain PRN.
Intervention: Dilaudid Injectable Product
Standard of Care (Control)
Regimen #2 STANDARD Postoperative Regimen 1. Once out of the PACU patients will receive "Standard" postoperative regimen 2. Motrin 600mg PO every 4 hours PRN pain scale 1-3 pain 3. Percocet 1 tab PO every 4-6 hours PRN pain scale 4-6 pain 4. Percocet 2 tabs PO every 7-10 hours PRN pain scale 7-10 pain 5. Patients will receive dilaudid 0.2mg IV every 3 hours PRN for breakthrough pain. 6. Patients will be discharged home with Motrin and Percocet for pain PRN.
Intervention: Percocet 5Mg-325Mg Tablet
Outcomes
Primary Outcomes
POD1 Visual Analog Pain (VAS) Score
Time Frame: Morning of post operative day 1 (~24 hours after surgery)
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)
Secondary Outcomes
- POD1 Quality of Recovery Score(Postoperative Day 1)
- 1st 24hr Total Dose of Narcotic(Total narcotic use from intra-op to 24 hours post-op)
- Length of Stay(Post-operative Day 1)
- POD4 VAS Scores(VAS Scores at 4 days post-surgery.)
- POD4 Quality of Recovery(Postoperative Day 4)
- POD4 Satisfaction Score(Data collected as of postoperative day 4)
- Time to First Bowel Movement(Up to post op day 4)
- Oxycodone 5mg Doses Taken Since Discharge(Data collected as of Postoperative day 4)