Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 48 Hours Morphine Equivalents Consumed.
研究概览
简要总结
The study's objective is to determine the efficacy of preoperative gabapentin in relieving postoperative pain, reducing opioid use and improving quality of recovery in subjects undergoing urologic surgery.
Investigators hypothesize that subjects receiving gabapentin will have lower pain scores, less opioid consumption and better quality of recovery as compared to subjects who are given a placebo.
详细描述
Approximately one hour prior to induction of anesthesia in preoperative holding area all enrolled subjects will receive PO Acetaminophen 650 mg, the Gabapentin group will receive PO Gabapentin 1200 mg, while the Control group will receive PO Placebo, with a small amount of water.
Upon arrival in the operating room, standard ASA monitors will be applied. Intraoperative, patients will receive a standardized anesthetic care. This care consists of induction with IV propofol 2mg/kg, IV fentanyl 2 mcg/kg (adjusted body weight), and IV rocuronium 0.6 mg/kg for tracheal intubation or IV succinylcholine 1mg/kg if rapid sequence induction is needed.
For maintenance of general anesthesia, investigators will use Sevoflurane, with the goal to maintain BP within 20% of preoperative baseline and BIS 40-60.
If HR > 100/min and BIS 40-60 may use IV esmolol 0.5 mg/kg. If BP and/or HR >20% preoperative baseline, and BIS 40- 60 despite above management, may titrate IV antihypertensive agents.
For PONV prophylaxis, 30 min before end of surgery investigatorswill administer IV ondansetron 8mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 75 years
- •Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy with Ureteral stent placement
排除标准
- •Age less than 18 or more than 75 years
- •Acetaminophen allergy
- •Gabapentin allergy
- •Hydromorphone allergy
- •Chronic use of gabapentin
- •History of chronic pain (Pain for > than 3 months)
- •Chronic renal insufficiency (Creatinine > 1.3)
- •Seizure disorder
- •Psychiatric disorders (medically treated)
- •Chronic use of anticonvulsants, antidepressants, antipsychotics (use > 3 months)
- •Antacids ingested within 2 hours prior to surgery
- •History of gastric or duodenal ulcer
- •Pregnant or lactating
- •Inability to communicate in English
研究组 & 干预措施
Placebo
Placebo pill administered 1 hour before planned surgical procedure
干预措施: Placebo (Drug)
Gabapentin
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
干预措施: Gabapentin (Drug)
结局指标
主要结局
48 Hours Morphine Equivalents Consumed.
时间窗: Up to 48 hours after surgery
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
次要结局
- 24 Hour Pain Burden(24 hours after surgery)
- QOR 40 Questionnaire Scores(48 hours after surgical procedure)
研究者
Luminita M. Tureanu
Principal Investigator
Northwestern University