Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery

Phase 4

Completed

Conditions: Pain, Postoperative
Pelvic Organ Prolapse

Interventions: Drug: Ice T
Drug: Motrin/Percocet/Dilaudid for breakthrough

Registration Number: NCT03052816

Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 66

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICE T	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.
Standard	Motrin/Percocet/Dilaudid for breakthrough	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scores (VAS)	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 Outcome Measures

Name	Time	Method
VAS Scores 96 Hours After 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.
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.	Number of participants with urinary retention (discharge home with foley)
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	Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge.
VAS Scores at 4 Hours Post Surgery	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.
Satisfaction Scores 96 Hours After Surgery	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.
Length of Stay	Time from end of surgery to discharge home from hospital, assessed up to 1 week.	Length of time from the end of surgery to discharge home from the 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	Number of patients with postoperative nausea and vomiting at 7AM after surgery
Quality of Recovery Scores on Post op Day 1	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.
Satisfaction Scores in the Morning After Surgery (7AM)	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.