ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

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

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.

• 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

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: None (Open Label)

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).; If patients requested additional opioids prior to POD4 they were given a supplemental narcotic prescription to ensure adequate pain control	Drug: Ketorolac; Use of non-steroidal anti-inflammatory drug for pain control postoperatively; Other Names: Toradol; Drug: Opioids; Use of narcotic for pain control postoperatively; Other Names: Oxycodone; Other: Ice Packs; Placement of Ice packs on surgical sites postoperatively; Drug: Tylenol; Use of pain medication postoperatively; Other Names: Acetaminophen; Drug: Dilaudid Injectable Product; Use of narcotic for pain control postoperatively; Other Names: Hydromorphone
Active Comparator: Standard of Care (Control); 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; Use of narcotic for pain control postoperatively; Other Names: Oxycodone; Drug: Dilaudid Injectable Product; Use of narcotic for pain control postoperatively; Other Names: Hydromorphone; Drug: Motrin; Use of non-steroidal anti-inflammatory drug for pain control postoperatively; Other Names: Ibuprofen; Drug: Percocet 5Mg-325Mg Tablet; Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively; Other Names: Oxycodone-Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POD1 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
POD1 Quality of Recovery Score	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.	Postoperative Day 1
1st 24hr Total Dose of Narcotic	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.	Total narcotic use from intra-op to 24 hours post-op
Length of Stay	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.	Post-operative Day 1
POD4 VAS Scores	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)	VAS Scores at 4 days post-surgery.
POD4 Quality of Recovery	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.	Postoperative Day 4
POD4 Satisfaction Score	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.	Data collected as of postoperative day 4
Time to First Bowel Movement	Time to first bowel movement in days	Up to post op day 4
Oxycodone 5mg Doses Taken Since Discharge	The number of oxycodone 5mg doses (whether as oxycodone 5mg or as percocet 5/325) taken since discharge up until postoperative 4.	Data collected as of Postoperative day 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
"ICE-T" Arm Patients Who Requested Supplemental Narcotics in Addition to Their ICE-T Regimen	Enrolled patients were randomized at the end of surgery to 1 of 2 postoperative pain regimens: ICE-T opioid-sparing regimen or the Standard opioid-centric regimen. The pain regimen protocols began upon PACU discharge. Subjects received their regimens as assigned, except that patients assigned to the ICE-T opioid-sparing group who requested additional narcotic medications prior to postoperative day 4 were prescribed supplemental opioids in addition to their ICE-T regimen medications.	Up until postoperative day 4

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

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; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Ketorolac; Hydromorphone; Ibuprofen; Oxycodone
• 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