CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 66 enrolled
Drug / intervention
Ice T +1 moredrug
Likely dose
Ice/Tylenol/Toradol with dilaudid for breakthrough (ICE-T regimen) versus Motrin/Percocet/Dilaudid for breakthrough (standard regimen)AI-extracted
Key inclusion· 3
  • ✓Women age 18-80 undergoing same-day vaginal pelvic reconstructive surgery (anterior/posterior repair, sacrospinous fixation, vaginal hysterectomy, sling, etc.)
  • ✓Able to read and understand VAS pain scores
  • ✓English speaking
Key exclusion· 10
  • ✕History of chronic pelvic pain
  • ✕Prior abdominal or laparoscopic surgery
  • ✕History of psychiatric disease
  • ✕Currently taking analgesic or sedative medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03052816
NCT03052816Phase 4Completed
CompareCT.gov

ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial

University Hospitals Cleveland Medical Center·interventional·Posted Feb 14, 2017·Updated May 19, 2023

In Brief

A Phase 4 clinical trial evaluating Ice T and Motrin/Percocet/Dilaudid for breakthrough for Pain, Postoperative and Pelvic Organ Prolapse. Completed, enrolled 66 participants across 1 site.

Detailed Summary

The purpose of this randomized controlled trial is to determine whether, "ICE-T," a novel multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Pelvic Organ Prolapse
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartApr 1, 2017
Primary CompletionJun 1, 2018
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.4 years ago

Interventions

Ice Tdrug

Ice/Tylenol/Toradol with dilaudid for breakthrough

Motrin/Percocet/Dilaudid for breakthroughdrug

Standard regimen