Clinical Trial: Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Usak State Hospital

Current Primary Outcome: Reduction of pain or paresthesia severity [ Time Frame: one month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: duration of relief of pain or paresthesia [ Time Frame: three month ]

Original Secondary Outcome: Same as current

Information By: Usak State Hospital

Dates:
Date Received: November 28, 2008
Date Started: November 2007
Date Completion:
Last Updated: December 1, 2008
Last Verified: November 2008