Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")
Anahtar kelimeler
Öz
Açıklama
This study will be a randomized double blinded placebo controlled trial. All women presenting to Mount Sinai Hospital eligible for surgery with pelvic organ prolapse symptoms requiring hysterectomy with other pelvic reconstruction (repair of cystocele and/or rectocele, with or without TVT) will be provided with a written informed consent to be randomized to either receiving pre-operative gabapentin single dose or placebo 2 hours prior to surgery. The single dose of gabapentin will be 600 mg for patients under 65 years old and 300 mg for those 65 years old and above. All patients will have pre-operative assessment according to the usual routine that will include urogynecological history taking, physical examination, urodynamic testing and blood work. Urodynamic testing will include measurement of the post-void residual by urethral catheterization or bladder scan, uroflowmetry, a filling cystometrogram and urethral pressure profilometry. Medication and placebo will be prepared by the hospital pharmacy to look alike to blind staff and patients. Medication or placebo will be given with other pre-anesthesia medications such as celecoxib and acetaminophen according to usual protocol. Routine peri-operative surgical/anesthesia management will be unchanged from the usual care. Post-operative pain score will be measured using a visual analogue scale (VAS) from 1 to 10. Total Opioids use during the first 24 hours after surgery will be calculated from patients' paper and electronic chart, and conversion will be made to morphine equivalents.
Tarih
Son Doğrulandı: | 01/31/2017 |
İlk Gönderilen: | 12/16/2016 |
Tahmini Kayıt Gönderildi: | 12/16/2016 |
İlk Gönderilen: | 12/20/2016 |
Son Güncelleme Gönderildi: | 02/11/2017 |
Son Güncelleme Gönderildi: | 02/13/2017 |
Fiili Çalışma Başlangıç Tarihi: | 12/31/2016 |
Tahmini Birincil Tamamlanma Tarihi: | 08/31/2017 |
Tahmini Çalışma Tamamlanma Tarihi: | 12/31/2017 |
Durum veya hastalık
Müdahale / tedavi
Drug: gabapentin
Other: placebo
Evre
Kol Grupları
Kol | Müdahale / tedavi |
---|---|
Experimental: gabapentin gabapentin 300-600 mg 1 hour preop | Drug: gabapentin Gabapentin 300-600 mg 1 hour preop |
Placebo Comparator: placebo placebo capsule(s) 1 hour preop | Other: placebo placebo capsule(s) 1 hour preop |
Uygunluk kriterleri
Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
Çalışmaya Uygun Cinsiyetler | Female |
Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
Kriterler | Inclusion Criteria: - women age 18 years and older - uterovaginal prolapse with or without stress urinary incontinence - booked for vaginal hysterectomy, anterior and/or posterior vaginal repair, with or without TVT Exclusion Criteria: - Women already on gabapentin for other indications - Women with proven allergy or sensitivity to gabapentin - Women with a contraindication to gabapentin - Women unable to understand spoken English |
Sonuç
Birincil Sonuç Ölçütleri
1. opioid consumption postop [24 hours]