ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

Phase 4

Completed

Conditions: Opioid Substitution Treatment

Interventions: Drug: Ketorolac
Drug: Opioids
Drug: Motrin
Other: Ice Packs
Drug: Tylenol
Drug: Percocet 5Mg-325Mg Tablet
Drug: Dilaudid Injectable Product

Registration Number: NCT03987022

Lead Sponsor: MetroHealth Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 66

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"ICE-T"	Ketorolac	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
"ICE-T"	Opioids	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
"ICE-T"	Ice Packs	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
"ICE-T"	Tylenol	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
"ICE-T"	Dilaudid Injectable Product	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
Standard of Care (Control)	Opioids	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.
Standard of Care (Control)	Motrin	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.
Standard of Care (Control)	Dilaudid Injectable Product	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.
Standard of Care (Control)	Percocet 5Mg-325Mg Tablet	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.

Primary Outcome Measures

Name	Time	Method
POD1 Visual Analog Pain (VAS) Score	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 Outcome Measures

Name	Time	Method
POD1 Quality of Recovery Score	Postoperative Day 1	QoR-40 is a quality of recovery 40-item questionnaire based on how the patient has felt in the past 24 hours. It provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It is a measure of postoperative quality of recovery in a range of clinical and research situations.
1st 24hr Total Dose of Narcotic	Total narcotic use from intra-op to 24 hours post-op	Total amount of narcotic in morphine equivalents administered to patients who were admitted for overnight extended recovery and/or observation. This includes narcotics given intra-operatively, in the post-anesthesia care unit and during their inpatient stay up until 24 hours postop.
Length of Stay	Post-operative Day 1	Length of hospital stay measured in the number of nights spent at the hospital. Subjects were given the option for same-day discharge home from the PACU or overnight inpatient observation.
POD4 VAS Scores	VAS Scores at 4 days post-surgery.	Visual Analog Scores 4 days post-surgery. VAS pain score of 0 to a score of worst pain indicating a score of 10 (0=no pain and 10=being worst pain ever)
POD4 Quality of Recovery	Postoperative Day 4	QoR-40 is a quality of recovery 40-item questionnaire based on how the patient has felt in the past 24 hours. It provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It is a measure of postoperative quality of recovery in a range of clinical and research situations.
POD4 Satisfaction Score	Data collected as of postoperative day 4	Patient's satisfaction with their pain management as of postoperative day 4, rated on a scale of 1 - 10, where 1 is very dissatisfied and 10 is very satisfied.
Time to First Bowel Movement	Up to post op day 4	Time to first bowel movement in days
Oxycodone 5mg Doses Taken Since Discharge	Data collected as of Postoperative day 4	The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4.