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) - GAP Study: Gabapentin in Post Surgery Pain

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 1,500 人开始时间: 2017年10月20日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Participant may enter study if ALL of the following apply:
•1. Over 18 years of age;
•2. Undergoing non-emergency surgery:
•- Cardiac (surgery on the heart and great vessels carried out via midline sternotomy);
•- Thoracic surgery (open or minimal access surgery on the lungs and surrounding tissues);
•- 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 750
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 750

•Participants may not enter study (i.e. may not be randomised) if ANY of the following apply:
•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) <30ml/min/1.732);
•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.

发起方

niversity Hospitals Bristol NHS Foundation Trust