ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ice T
- Conditions
- Pain, Postoperative
- Sponsor
- University Hospitals Cleveland Medical Center
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Visual Analog Scores (VAS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
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.
Arms & Interventions
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.
Intervention: Ice T
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.
Intervention: Motrin/Percocet/Dilaudid for breakthrough
Outcomes
Primary Outcomes
Visual Analog Scores (VAS)
Time Frame: Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.
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.
Secondary Outcomes
- VAS Scores 96 Hours After Surgery(VAS Scores 96 hours after surgery)
- Number of Participants With Urinary Retention.(Number of participants with urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.)
- Total Dose of Opioids Administered During Hospitalization(Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week)
- VAS Scores at 4 Hours Post Surgery(VAS Scores at 4 hours post surgery)
- Satisfaction Scores 96 Hours After Surgery(Satisfaction scores 96 hours after surgery)
- Length of Stay(Time from end of surgery to discharge home from hospital, assessed up to 1 week.)
- Postoperative Nausea and Vomiting at 7AM After Surgery(Postoperative nausea and vomiting from the time to end of surgery until 7AM 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))