Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

NCT ID: NCT03052816

Last Updated: 2023-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-06-30

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.

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.

Conditions

Pain, Postoperative; Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICE T

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.

Group Type: EXPERIMENTAL

Ice T

Intervention Type: DRUG

Ice/Tylenol/Toradol with dilaudid for breakthrough

Standard

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.

Group Type: ACTIVE_COMPARATOR

Motrin/Percocet/Dilaudid for breakthrough

Intervention Type: DRUG

Standard regimen

Interventions

Ice T

Ice/Tylenol/Toradol with dilaudid for breakthrough

Intervention Type: DRUG

Motrin/Percocet/Dilaudid for breakthrough

Standard regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31201808 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-00498

Identifier Type: -

Identifier Source: org_study_id