Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery (NCT03052816) | Clinical Trial Compass
CompletedPhase 4
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
United States66 participantsStarted 2017-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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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 vaginal female pelvic reconstructive surgery at MetroHealth Medical Center
* Ability to read VAS Scores
* Specific vaginal procedures include, but are not limited to:
* Periurethral bulking
* Perineoplasty
* Complete vaginectomy
* Le Forte colpocleisis
* Anterior repair
* Posterior repair
* Enterocele repair
* Anterior and posterior repair
* Anterior, posterior and enterocele repair
* Transvaginal mesh use
* Sacrospinous ligament fixation
* Uterosacral ligament suspension
* Vaginal paravaginal defect repair
* Midurethral Sling
* Sphincteroplasty
* Vaginal hysterectomy, for uterus 250 g or less
* Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s)
* Vaginal hysterectomy, for uterus 250 g or less; with removal of tube(s), and/or ovary(s), with repair of enterocele
* Vaginal hysterectomy, for uterus 250 g or less; with repair of enterocele
* Vaginal hysterectomy, for uterus greater than 250 g
* Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s)
* Vaginal hysterectomy, for uterus greater than 250 g; with removal of tube(s) and/or ovary(s), with repair of enterocele
* Vaginal hysterectomy, for uterus greater than 250 g; with repair of enterocele
Exclusion Criteria:
* The exclusion criteria are the following…
What they're measuring
1
Visual Analog Scores (VAS)
Timeframe: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
Trial details
NCT IDNCT03052816
SponsorUniversity Hospitals Cleveland Medical Center