Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Lead SponsorUsak State Hospital
StatusCompleted No Results Posted
Indication/ConditionChest Pain Paresthesia
Intervention/Treatmentdiclofenac gabapentin ...
In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.
Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.
Gabapentin 800 mg one a day up to 30 day
Diclofenac 75 mg one a day up to 30 day
Inclusion Criteria: Poststernotomy chest pain and/or paresthesia Exclusion Criteria: Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.) Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases Over production of scar tissue, thoracic surgery other than sternotomy - Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass