Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
Condition: Pain, Postoperative; Pelvic Organ Prolapse
MeSH terms: Prolapse; Pain, Postoperative; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ice T; Motrin/Percocet/Dilaudid for breakthrough
Intervention type(s): Drug; Drug
Intervention description(s): Ice/Tylenol/Toradol with dilaudid for breakthrough; Standard regimen
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment