ISRCTN63614165进行中（未招募）4 期
Effectiveness, cost effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: A placebo controlled randomised controlled trial with blinding (The GAP study)
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 1,196 人开始时间: 2017年6月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,196
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33444208/ protocol (added 15/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 18/01/2019:
- •1. Over 18 years of age
- •2. Undergoing non-emergency surgery:
- •2.1. Cardiac (surgery on the heart and great vessels carried out via midline sternotomy)
- •2.2. Thoracic surgery (open or minimal access surgery on the lungs and surrounding tissues)
- •2.3. Abdominal (open or minimal access surgery within the abdominal cavity)
- •3. Expected to stay in hospital at least until day 2 after surgery (day 0 is day of surgery)
- •4. Expected to be able to swallow during the time of the study intervention
- •Previous inclusion criteria:
- •1. Over 18 years of age
- •2. Undergoing non-emergency surgery:
- •2.1. Cardiac (surgery on the heart and great vessels carried out via midline sternotomy)
- •2.2. Thoracic surgery (surgery on the lungs and surrounding tissues)
- •2.3. Abdominal (open or laparoscopic surgery within the abdominal cavity)
排除标准
- •Current exclusion criteria as of 18/01/2019:
- •1. Taking anti-epileptic medication(s)
- •2. Allergy to gabapentin
- •3. Already taking gabapentin or gabapentanoids
- •4. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption
- •5. Planned epidural analgesia
- •6. Intended use of any gabapentanoids in the peri-operative analgesic protocol other than the study medication (this includes but is not restricted to: pregabalin, enacarbil gabapentin, 4-methylpregabalin and phenibut)
- •7. Known renal impairment (for such patients, estimated glomerular filtration rate (eGFR)
- •8. Weight <50kg
- •9. Inability to provide written informed consent to participate in the trial
- •10. Unwilling to participate in follow-up
- •11. Prisoners
- •12. Enrolled in another clinical trial and: a) the patient is currently taking an investigational medicinal product as part of the other trial; or b) co-enrolment is not permitted by the other trial; or c) co-enrolment would be burdensome for the patient
- •Previous exclusion criteria:
- •1. Expected to have a minimum length of hospital stay of less than 2 days
- •2. Taking anti-epileptic medication(s)
- •3. Allergy to gabapentin
- •4. Planned epidural analgesia
- •5. Intended use of any gabapentanoids in the peri-operative analgesic protocol other than the study medication (this includes but is not restricted to: pregabalin, enacarbil gabapentin, 4-methylpregabalin and phenibut)
- •6. Known renal impairment (for such patients, estimated glomerular filtration rate (eGFR) <30ml/min/1.732)
- •7. Weight <50kg
- •8. Inability to provide written informed consent to participate in the trial
- •9. Unwilling to participate in follow-up
- •10. Prisoners
- •11. Already taking gabapentin or gabapentanoids
- •12. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption
- •13. Currently taking an investigational medicinal product as part of another clinical trial
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