A Randomized Controlled Trial to Determine the Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores in Patients Having Hip and Knee Arthroplasties With Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Time Weighted Average Pain Score in Numerical Rating Scores
研究概览
简要总结
Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease your need for narcotics and thus decrease the risk of side effects. The investigator hopes this study will determine if gabapentin enacarbil decreases opioid consumption and pain after surgery.
Patients having elective hip and knee surgery will be asked to participate in the study. Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo twice per day for 5 days.
One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil 600mg or placebo 600mg two hours before the surgical procedure. Six hours after the completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg. If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or placebo 600mg pills to take home along with instructions. However, if the patient remains hospitalized, on the first day after the surgery, the patient will have pain assessed in the morning using a numerical rating score. The patient's quality of recovery will be evaluated using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. The second and third day the patient is in the hospital, the patient will have pain assessed in the morning using a numerical rating score and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three months after surgery, the patient will receive a phone call to follow-up with possible pain or discomfort the patient may be feeling.
详细描述
A randomized controlled trial to determine the effect of gabapentin enacarbil on opioid consumption and pain scores in patients having primary hip or knee replacement surgery with spinal anesthesia.
Screening visit
- Consent will be obtained
- Vital Signs
- Physical evaluation
- Medical History
- Laboratory values and medication checked via Epic
- Pain scores using numerical rating scores (NRS)
- Brief pain inventory (BPI)
- Randomization will be to standard management with GEn or to standard management with placebo. Patients will be given GEn 600 mg bid or placebo 600 mg bid for 1 preoperative day and will receive 600 mg GEn or placebo about 2 hours before surgery and then restarted on GEn or placebo 600 mg within 6 hours of surgery, and then 600 mg bid for three additional days.
2 days prior to surgery Phone call will be made to remind patients to take GEn 600 mg bid or placebo 600 mg bid
1 day prior to surgery
- vital signs
- GEn 600 mg bid or placebo 600 mg bid
- monitoring and recording of adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18-85 years of age.
- •Scheduled for elective knee or hip arthroplasty with spinal anesthesia.
排除标准
- •Creatinine >1.50 mg/dl.
- •History of clinically important current depression or currently on any prescribed anti-depressant medication.
- •Previously enrolled in any Xenoport trial.
- •Use of gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise) within one month.
- •Allergy to gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise).
- •Women who are pregnant or breastfeeding.
- •History of seizure disorder within the last one-year or taking medications for seizures.
研究组 & 干预措施
Gabapentin enacarbil
Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days
干预措施: Gabapentin enacarbil (Drug)
Placebo
Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time Weighted Average Pain Score in Numerical Rating Scores
时间窗: Initial 72 hours after surgery or until discharge, whatever comes first.
Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient
Cumulative Postoperative Opioid Consumption
时间窗: Initial 72 hours after surgery or until discharge, whatever comes first.
The total dose of opioid administered in the PACU and floor including the background analgesia (PCA) and boluses. All opioids will be converted into mg intravenous (IV) morphine equivalent to standardize opioid consumption .
次要结局
- Number of Participants With Persistent Pain 90-day After Surgery(within 90 days after surgery)
- Length of Hospital Stay in Hours(From the end of surgery to discharge)
- Postoperative Nausea and Vomiting (PONV) up to 72 Hours After Surgery(Initial 72 hours after surgery)
- Quality of Recovery (QoR-15) Score 72 Hours After Surgery(Initial 72 hours after surgery or shortly before hospital discharge.)