Phase 4
Completed N=66
Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
Pain, Postoperative · pelvic organ prolapse
Source: ClinicalTrials.gov NCT03052816 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Visual Analog Scores (VAS) — 20; 40 mm
◆ Published Evidence
Established
45citations · ~6 / year
Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.
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.
Linked Publications
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Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scores (VAS) |
20; 40 | — |
| SECONDARY VAS Scores at 4 Hours Post Surgery |
35; 50 | — |
| SECONDARY VAS Scores 96 Hours After Surgery |
20; 30 | — |
| SECONDARY Quality of Recovery Scores on Post op Day 1 |
182; 173 | — |
| SECONDARY Satisfaction Scores in the Morning After Surgery (7AM) |
10; 10 | — |
| SECONDARY Satisfaction Scores 96 Hours After Surgery |
10; 9 | — |
| SECONDARY Length of Stay |
24.1; 24.1 | — |
| SECONDARY Total Dose of Opioids Administered During Hospitalization |
55.7; 91.2 | — |
| SECONDARY Postoperative Nausea and Vomiting at 7AM After Surgery |
14; 18 | — |
| SECONDARY Number of Participants With Urinary Retention. |
5; 7 | — |
Eligibility Criteria
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:
- History of chronic pelvic pain
- Abdominal surgery
- Laparoscopic 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 or laparoscopic 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 (NCT03052816) and the linked publication. 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.