Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery (ICET)

ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Pelvic Organ Prolapse
• Intervention / Treatment: Drug: Ice T; Drug: Motrin/Percocet/Dilaudid for breakthrough

Detailed Description

Pelvic floor disorders involve a myriad of complicated, interwoven clinical conditions that involve pelvic organ prolapse, urinary incontinence, fecal incontinence, and other pathology involving the genital and lower urinary tract. It is estimated that pelvic floor disorders affect up to 25% of all adult women in the United States with increasing prevalence with age. By the age of sixty, 1 in 9 women will undergo surgical intervention for pelvic organ prolapse and/or incontinence, increasing to 1 in 5 by the age of 80. As the population in the United States ages, the demand for healthcare for pelvic floor disorders is estimated to increase up to 40% in the next 30 years.

Despite the prevalence of surgery performed for pelvic floor disorders, there is a paucity of data on postoperative pain control that is dedicated to female pelvic reconstructive surgery. In a recent review, there was only one study that evaluated postoperative pain control after vaginal reconstructive surgery, and the mainstay of therapy was opioid driven. Generally, postoperative pain control in gynecologic surgery has been opioid driven, frequently involving multiple narcotics for analgesia, resulting opioid related complications, including nausea, vomiting, constipation, urinary retention, and central nervous system side effects In an effort to combat opioid use in gynecologic and female pelvic reconstructive surgery, multimodal therapy has been gaining momentum with goals of improved pain control and decreased opioid requirements. Ice packs, toradol, and acetaminophen have been used in various trials to decrease postoperative opioid requirements in various surgeries.

Ice packs have been shown to be effective in the treatment of postoperative pain after abdominal midline incisions. A Cochrane Review of patients subject to post vaginal delivery perineal cooling included 10 randomized controlled trials with1825 patients with some evidence that local cooling in the form of ice packs, cold gel packs, cold/ice backs may be effective in pain relief.

Toradol has been extensively studied in a multitude of surgeries including spinal, obstetric, orthopedic, urologic, and gynecologic. It has been administered preemptively, intraoperatively, and postoperatively for pain control with evidence that toradol decreases postoperative subjective pain scores and decreased narcotic use.

Acetaminophen is mainstay for postoperative pain control as part of multimodal pain regimens to complement other, opioid sparing medications in a multitude of surgeries including abdominal hysterectomy.

Therefore, the purpose of this randomized controlled study 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 and decrease opioid intake compared to the standard postoperative pain regimen in patients undergoing vaginal pelvic floor reconstructive surgery.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICE T; ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.; 6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.; Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge; Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.; Patients will be discharged home with PO Tylenol and PO toradol PRN.	Drug: Ice T; Ice/Tylenol/Toradol with dilaudid for breakthrough
Active Comparator: Standard; Motrin 600mg PO Q4h PRN pain 1-3; Percocet 1 tab PO Q4-6 hours PRN 4-6 pain; Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain; Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.; Patients will be discharged home with Motrin and Percocet for pain PRN.	Drug: Motrin/Percocet/Dilaudid for breakthrough; Standard regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Scores at 4 Hours Post Surgery	VAS Scores at 4 hours post surgery. 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.	VAS Scores at 4 hours post surgery
VAS Scores 96 Hours After Surgery	VAS Scores 96 hours after surgery. 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.	VAS Scores 96 hours after surgery
Quality of Recovery Scores on Post op Day 1	Quality of Recovery scores on post op day 1. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient's health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.	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). The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.	Satisfaction scores in the morning after surgery (7AM)
Satisfaction Scores 96 Hours After Surgery	Satisfaction scores 96 hours after surgery. The satisfaction score is a numerical score from 0-10 with a score of 0 indicating very dissatisfied on the left of the scale and 10 indicating very satisfied on the right of the scale.	Satisfaction scores 96 hours after surgery
Length of Stay	Length of time from the end of surgery to discharge home from the hospital, assessed up to 1 week.	Time from end of surgery to discharge home from hospital, assessed up to 1 week.
Total Dose of Opioids Administered During Hospitalization	Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.	Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week
Postoperative Nausea and Vomiting at 7AM After Surgery	Number of patients with postoperative nausea and vomiting at 7AM after surgery	Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery
Number of Participants With Urinary Retention.	Number of participants with urinary retention (discharge home with foley)	Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse; Pelvic Organ Prolapse; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: 16-00498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No