NCT03987022

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: MetroHealth Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Substitution Treatment

Interventions

Type	Name	Description
DRUG	Ketorolac	Use of non-steroidal anti-inflammatory drug for pain control postoperatively
DRUG	Opioids	Use of narcotic for pain control postoperatively
OTHER	Ice Packs	Placement of Ice packs on surgical sites postoperatively
DRUG	Tylenol	Use of pain medication postoperatively
DRUG	Motrin	Use of non-steroidal anti-inflammatory drug for pain control postoperatively
DRUG	Dilaudid Injectable Product	Use of narcotic for pain control postoperatively
DRUG	Percocet 5Mg-325Mg Tablet	Use of combination tablet of Tylenol and Oxycodone for pain control postoperatively

Timeline

• Start date: 2019-08-01
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2019-06-14
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study