---
title: ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
nct_id: NCT03987022
overall_status: COMPLETED
phase: PHASE4
sponsor: MetroHealth Medical Center
study_type: INTERVENTIONAL
primary_condition: Opioid Substitution Treatment
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03987022.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03987022"
ct_last_update_post_date: 2025-01-24
last_seen_at: "2026-05-12T06:23:05.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

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

**NCT ID:** [NCT03987022](https://clinicaltrials.gov/study/NCT03987022)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 66
- **Lead Sponsor:** MetroHealth Medical Center
- **Conditions:** Opioid Substitution Treatment
- **Start Date:** 2019-08-01
- **Completion Date:** 2022-04-25
- **CT.gov Last Update:** 2025-01-24

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **"ICE-T"** (EXPERIMENTAL) — 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)** (ACTIVE_COMPARATOR) — 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.

## Interventions

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

## 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** _(time frame: Postoperative Day 1)_
- **1st 24hr Total Dose of Narcotic** _(time frame: Total narcotic use from intra-op to 24 hours post-op)_
- **Length of Stay** _(time frame: Post-operative Day 1)_
- **POD4 VAS Scores** _(time frame: VAS Scores at 4 days post-surgery.)_
- **POD4 Quality of Recovery** _(time frame: Postoperative Day 4)_
- **POD4 Satisfaction Score** _(time frame: Data collected as of postoperative day 4)_
- **Time to First Bowel Movement** _(time frame: Up to post op day 4)_
- **Oxycodone 5mg Doses Taken Since Discharge** _(time frame: Data collected as of Postoperative day 4)_

## Locations (1)

- MetroHealth Medical Center, Cleveland, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.metrohealth medical center|cleveland|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03987022.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03987022*  
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