Ice T Postoperative Multimodal Pain Regimen in FPMRS Surgery
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 11/30/2018 |
| İlk Gönderilen: | 01/30/2017 |
| Tahmini Kayıt Gönderildi: | 02/08/2017 |
| İlk Gönderilen: | 02/13/2017 |
| Son Güncelleme Gönderildi: | 12/14/2018 |
| Son Güncelleme Gönderildi: | 12/18/2018 |
| Fiili Çalışma Başlangıç Tarihi: | 01/29/2017 |
| Tahmini Birincil Tamamlanma Tarihi: | 05/31/2018 |
| Tahmini Çalışma Tamamlanma Tarihi: | 06/29/2018 |
Durum veya hastalık
Müdahale / tedavi
Drug: ICE T
Drug: Standard
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Experimental: ICE T ICE PACKS applied to the perineum every hour for 20 minutes ATC until discharge.
6 hours from the time of first dose of surgery patients will receive 30mg of IV toradol ATC until discharge.
Once out of the PACU will receive 1 gram of Tylenol every 6 hours for a total of 4 grams daily ATC until discharge
Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
Patients will be discharged home with PO Tylenol and PO toradol PRN. | Drug: ICE T Ice/Tylenol/Toradol with dilaudid for breakthrough |
| Active Comparator: Standard Motrin 600mg PO Q4h PRN pain 1-3
Percocet 1 tab PO Q4-6 hours PRN 4-6 pain
Percocet 2 tabs PO Q 7-10 hours PRN 7-10 pain
Patients will receive dilaudid 0.2mg IV Q3 hr PRN for breakthrough pain.
Patients will be discharged home with Motrin and Percocet for pain PRN. | Drug: Standard Standard regimen |
Uygunluk kriterleri
| Çalışmaya Uygun Cinsiyetler | Female |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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 |
Sonuç
Birincil Sonuç Ölçütleri
1. Visual Analog Scores (VAS) [Visual Analog Scores (VAS) Score in the morning of post op day 1 at 7am.]
İkincil Sonuç Ölçütleri
1. VAS Scores at 4 hours post surgery [VAS Scores at 4 hours post surgery]
2. VAS Scores at 12 hours [VAS scores at 12 hours]
3. VAS Scores 96 hours after surgery [VAS Scores 96 hours after surgery]
4. Quality of Recovery scores on post op day 1 [Quality of Recovery scores on post op day 1]
5. Satisfaction scores in the morning after surgery (7AM) [Satisfaction scores in the morning after surgery (7AM)]
6. Satisfaction scores 96 hours after surgery [Satisfaction scores 96 hours after surgery]
7. Length of stay [Length of stay in hours from the time of surgery to discharge f up to 1 week]
8. Hemoglobin difference preop/postop [Hemoglobin difference preop/post op from before surgical to after surgery on post operative day 1]
9. Total dose of opioids administered during hospitalization in morphine equivalents upon hospital discharge. [Total dose of opioids administered during hospitalization in morphine equivalents from the end of surgery to discharge up to 1 week]
10. Postoperative nausea and vomiting at 24 hours of surgery, dizziness, headache, blurry vision, pruritus, drowsiness within 24 hours after surgery. [Postoperative nausea and vomiting at 24 hours of surgery, dizziness, headache, blurry vision, pruritus, drowsiness within 24 hours after surgery/study completion.]
11. Time to first void [Time to first void measured from time of surgery to the first episode of voiding typically on the first post operative day/study completion]
12. Incidence of urinary retention (discharge home with foley) [Incidence of urinary retention (discharge home with foley) measured on day patient is discharged home/study completion up to 1 week.]
13. Time to first bowel movement (patients will ask to record this and there will be follow up via phone call 24 hours and 96 hours after surgery) [Time to first bowel movement (patients will ask to record this and there will be follow up via phone call 24 hours and 96 hours after surgery). Measured from end of surgery to the time patient reports first bowel movement in hours upon time of discharge.]
