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

Usak State Hospital

Status and phase

Completed

Phase 4

Conditions

Paresthesia

Chest Pain

Treatments

Drug: Diclofenac

Drug: Gabapentin

Study type

Interventional

Funder types

Other

Identifiers

NCT00800527

B4ISM4350015-009/295

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

15 to 85 years old

Volunteers

No Healthy Volunteers

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