ICE T for Post GYN Surgery Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Substitution Treatment
• Intervention / Treatment: Drug: Ketorolac; Other: Ice Packs; Drug: Tylenol; Drug: dilaudid; Drug: Opioids; Drug: Motrin

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "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; 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; Use of non-steroidal anti-inflammatory drug for pain control post operatively; Other Names: Toradol; Other: Ice Packs; Placement of Ice packs on surgical sites post operatively; Drug: Tylenol; Use of pain medication post operatively; Drug: dilaudid; Use of narcotic for pain control post operatively
Active Comparator: Standard of care; 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: dilaudid; Use of narcotic for pain control post operatively; Drug: Opioids; Use of narcotic for pain control post operatively; Other Names: Oxycodone; Drug: Motrin; Use of non-steroidal anti-inflammatory drug for pain control post operatively

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Investigators: Principal Investigator: Robert Pollard, MD, MetroHealth Medical Center

Publications and helpful links

Helpful Links

• ICE-T postoperative multimodal pain regimen compared to the standard regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Anti-inflammatory agents non-steroidal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Ketorolac; Acetaminophen; Oxycodone; Hydromorphone
• Other Study ID Numbers: IRB18-00920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No