Clinical trial NCT03052816: Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
Official title: ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Pelvic Organ Prolapse
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scores (VAS)
timeFrame: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
Secondary outcomes:
measure: VAS Scores at 4 Hours Post Surgery
timeFrame: VAS Scores at 4 hours post surgery
measure: VAS Scores 96 Hours After Surgery
timeFrame: VAS Scores 96 hours after surgery
measure: Quality of Recovery Scores on Post op Day 1
timeFrame: Quality of Recovery scores on post op day 1
measure: Satisfaction Scores in the Morning After Surgery (7AM)
timeFrame: Satisfaction scores in the morning after surgery (7AM)
measure: Satisfaction Scores 96 Hours After Surgery
timeFrame: Satisfaction scores 96 hours after surgery
measure: Length of Stay
timeFrame: Time from end of surgery to discharge home from hospital, assessed up to 1 week.
measure: Total Dose of Opioids Administered During Hospitalization
timeFrame: Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week
measure: Postoperative Nausea and Vomiting at 7AM After Surgery
timeFrame: Postoperative nausea and vomiting from the time to end of surgery until 7AM after surgery
measure: Number of Participants With Urinary Retention.
timeFrame: Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References:
citation: 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.