The Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Examine the efficacy of gabapentin in changing postoperative pain scores
研究概览
简要总结
Enhanced recovery after surgery (ERAS) has been synonymous with increasing non-opioid multimodal therapies and decreasing opioid therapies after surgery to improve perioperative care. Gabapentin has been standardized as part of routine adjuvant post-operative enhanced recovery protocols after other surgical specialties surgeries. Limited data is known about the specifics of routine adjuvant post-operative gabapentin in the realm of urogynecology. Sacrocolpopexy has been noted as a highly effective prolapse surgical treatment, especially with apical and multicompartment prolapse. In 2006, approximately 73% of all sacrocolpopexy across the nation are completed through a minimally invasive approach. The role of gabapentin as part of a postoperative pain protocol following minimally invasive sacrocolpopexy (MISC) has yet to be determined.
详细描述
This will be a randomized controlled pilot trial to determine the effect of a standard postoperative pain protocol with scheduled gabapentin versus placebo in decreasing post-operative pain scores. An institutional review board approach will be obtained and the trial will be registered at Clinicaltrials.gov and the protocol adhered to CONSORT guidelines.
Recruitment will start in October 2022 until completion of pilot study enrollment numbers at OU Health - a single academic center. If patients meet inclusion criteria (see below), willing participants will sign a written consent on their preoperative visit.
Researchers will be recruiting 20 patients per study arm: standard ERAS protocol post-operative care with placebo vs study group given standard ERAS protocol with scheduled postoperative gabapentin for the first two weeks following surgery.
Randomization will be computer generated, using a 1:1 allocation and variable block sizes of 2 and 4. Randomization and packing with opaque bags will be performed by our institution's investigation drug pharmacy. Consents will be signed by trained research assistant(s) and randomization should be maintained throughout the duration of enrollment. Patients will receive their medications concealed within an opaque bag given by the surgical team.
The primary outcome is pain during normal activity and rest via a standardized telephone prompt using the validated surgical pain scale (SPS) on POD 3-5 and 7-10. The SPS uses a numeric range from 0 to 10 with 0 representing no pain and 10 representing the worst pain imaginable. Pain scale will be assessed and opioid consumption will be measured at POD 14-16 during their routine follow up. Patients will be asked the number remaining opiate medications left at their follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients have a diagnosis of uterovaginal prolapse, vaginal vault prolapse, or pelvic organ prolapse (based on International Classification of Diseases [ICD]).
排除标准
- •Concurrent sphincter or fistula repair, urethral diverticulectomy or mesh excision
- •Current gabapentin or pregabalin use
- •Oxygen dependency
- •Renal failure or glomerular filtration rate of < 30mL/min
- •Daily narcotic usage >2 months - this is to allow us to capture an opiate-naïve patient population to better assess the impact of adjuvant gabapentin
研究组 & 干预措施
Placebo Arm
Standard ERAS protocol post-operative care with placebo
干预措施: Placebo (Drug)
Gabapentin Arm
Standard ERAS protocol with scheduled postoperative gabapentin
干预措施: Gabapentin (Drug)
结局指标
主要结局
Examine the efficacy of gabapentin in changing postoperative pain scores
时间窗: 2 weeks post-op
Measured using the validated surgical pain scale in which 0 (minimum value) means no pain sensation and 10 (maximum value) means most intense pain imaginable
次要结局
- Patient satisfaction(2 weeks post-op)
- Degree of somnolence(2 weeks post-op)
- Post-operative opioid consumption(2 weeks post-op)