Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Amount of morphine consumption
研究概览
简要总结
Total hip arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain in these patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reduced postoperative pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated for total joint arthroplasty patients.
详细描述
The study was submitted to Health Canada and has received the letter of no objection. A randomized, double-blind, placebo-controlled trial will be conducted. The randomization scheme will be prepared and done by the pharmacy department at McMaster University. Ninety patients undergoing primary hip arthroplasty will be recruited from the preoperative clinic. Forty-five patients in each population will be allocated to a gabapentin group and the other forty-five patients will be allocated to a placebo group.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants aged 19-90
- •elective single joint, primary total hip arthroplasty
- •use of PCA with morphine for postoperative pain control has been discussed and agreed upon between patient and anesthetist
排除标准
- •bilateral total hip arthroplasty
- •revision hip arthroplasty
- •underlying diseases of epilepsy, seizure, or chronic pain syndrome
- •active gastrointestinal bleeding within the last 6 months
- •history of non-steroidal anti-inflammatory drug (NSAID) induced asthma
- •known or suspected history of drug or alcohol abuse
- •participate currently takes gabapentin or pregabalin for any reason
- •participant currently takes pain medication that is more potency than codeine or oxycodone (morphine, hydromorphone, meperidine, methadone, fentanyl, including any long acting narcotics)
- •known allergy to study medications: gabapentin, morphine, NSAID, acetaminophen
- •unable to tolerate morphine
- •liver impairments
- •kidney impairment or calculated creatinine clearance by Cockcroft-Gault formula is <=60ml/min
- •pregnancy or breast-feeding
- •participant currently receives associated worker's compensation benefits (WSIB)
- •participant unable or unwilling to give written or informed consent
- •unable to use PCA
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Gabapentin
600mg of gabapentin will be given orally two hours preoperatively and 200mg for 3 times a day after surgery for three days.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Amount of morphine consumption
时间窗: Two years
次要结局
- Side effects(Two years)
- Pain scores(Two years)