ICE-T Pain Regimen for Total Laparoscopic Hysterectomy (NCT03987022) | Clinical Trial Compass
CompletedPhase 4
ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
United States66 participantsStarted 2019-08-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pro…
What they're measuring
1
POD1 Visual Analog Pain (VAS) Score
Timeframe: Morning of post operative day 1 (~24 hours after surgery)