NCT00800527

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Usak State Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Chest Pain
• Paresthesia

Interventions

Type	Name	Description
DRUG	Gabapentin	Gabapentin 800 mg one a day up to 30 day
DRUG	Diclofenac	Diclofenac 75 mg one a day up to 30 day

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-06-01
• Completion: 2008-10-01
• First posted: 2008-12-02
• Last updated: 2008-12-02

Locations

1 site across 1 country: Turkey (Türkiye)