Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")
Түлхүүр үгс
Хураангуй
Тодорхойлолт
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.
Огноо
Сүүлд баталгаажуулсан: | 01/31/2017 |
Эхлээд оруулсан: | 12/16/2016 |
Тооцоолсон элсэлтийг оруулсан: | 12/16/2016 |
Эхлээд нийтэлсэн: | 12/20/2016 |
Сүүлийн шинэчлэлтийг оруулсан: | 02/11/2017 |
Сүүлийн шинэчлэлтийг нийтэлсэн: | 02/13/2017 |
Сургалтын бодит эхлэх огноо: | 12/31/2016 |
Тооцоолсон анхан шатны ажил дуусах огноо: | 08/31/2017 |
Судалгааны ажлыг дуусгах өдөр: | 12/31/2017 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: gabapentin
Other: placebo
Үе шат
Arm Groups
Гар | Хөндлөнгийн оролцоо / эмчилгээ |
---|---|
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 |
Эрхийн шалгуур
Суралцах боломжтой нас | 18 Years Хэнд 18 Years |
Суралцах боломжтой хүйс | Female |
Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
Шалгуур үзүүлэлтүүд | 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 |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. opioid consumption postop [24 hours]