Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

NCT03052816 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 16-00498
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scores (VAS)

  Visual Analog Scores (VAS) Scores in the morning of post op day 1. The VAS is a 100mm scale with a score of no pain on the left of the scale, indicating a score of 0, and a score of worst pain on the right, indicating a score of 10. Patient is instructed to score the scale where they feel is appropriate. Each demarcation in between marks is 10mm and after the patient marks their score it is measured using mm from 0mm-100mm. A score of 0 is 0mm and a score of 10 is 100mm.

  Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.

Secondary Outcomes (9)

• VAS Scores at 4 Hours Post Surgery

  VAS Scores at 4 hours post surgery

• VAS Scores 96 Hours After Surgery

  VAS Scores 96 hours after surgery

• Quality of Recovery Scores on Post op Day 1

  Quality of Recovery scores on post op day 1

• Satisfaction Scores in the Morning After Surgery (7AM)

  Satisfaction scores in the morning after surgery (7AM)

• Satisfaction Scores 96 Hours After Surgery

  Satisfaction scores 96 hours after surgery

Study Arms (2)

ICE T

EXPERIMENTAL

1. ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge. 2. 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge. 3. Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with PO Tylenol and PO toradol PRN.

Drug: Ice T

Standard

ACTIVE COMPARATOR

1. Motrin 600mg PO Q4h PRN pain 1-3 2. Percocet 1 tab PO Q4-6 hours PRN 4-6 pain 3. Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain 4. Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain. 5. Patients will be discharged home with Motrin and Percocet for pain PRN.

Drug: Motrin/Percocet/Dilaudid for breakthrough

Interventions

Ice T DRUG

Ice/Tylenol/Toradol with dilaudid for breakthrough

ICE T

Motrin/Percocet/Dilaudid for breakthrough DRUG

Standard regimen

Standard

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only patients who undergo same day (\<24 hour) female pelvic reconstructive surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.

  PMID: 31201808 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pelvic Organ Prolapse

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Andrey Petrikovets MD
• Organization: UH Hospitals Cleveland Medical Center/MetroHealth Medical Center at time of study protocol

andrepetrikovets@yahoo.com

323 243 9091

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 14, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: May 19, 2023
• Results First Posted: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)