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Phase 4 N=66 Randomized Other

ICE-T Pain Regimen for Total Laparoscopic Hysterectomy

Opioid Substitution Treatment

Bottom Line

View on ClinicalTrials.gov: NCT03987022 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: POD1 Visual Analog Pain (VAS) Score — 5.8; 5 Score on a scale — p=.16

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Ketorolac (Drug); Opioids (Drug); Ice Packs (Other); Tylenol (Drug); Motrin (Drug); Dilaudid Injectable Product (Drug); Percocet 5Mg-325Mg Tablet (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
MetroHealth Medical Center
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
POD1 Visual Analog Pain (VAS) Score		 5.8; 5 .16
SECONDARY
POD1 Quality of Recovery Score		 161.5; 162.5 1.00
SECONDARY
1st 24hr Total Dose of Narcotic		 77; 111.5 .01 sig
SECONDARY
Length of Stay		 1; 1 1.00
SECONDARY
POD4 VAS Scores		 3; 4 .58
SECONDARY
POD4 Quality of Recovery		 179.5; 177.0 .47
SECONDARY
POD4 Satisfaction Score		 10.0; 8.0 0.4
SECONDARY
Time to First Bowel Movement		 2; 3 .02 sig
SECONDARY
Oxycodone 5mg Doses Taken Since Discharge		 0; 7.0 <0.001 sig

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03987022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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