Phase 4
Completed N=66
ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
Opioid Substitution Treatment
Source: ClinicalTrials.gov NCT03987022 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: POD1 Visual Analog Pain (VAS) Score — 5.8; 5 Score on a scale — p=.16
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-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 |
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
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. Informational only — not medical advice.