Trial | NCT00800527  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    110
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.
Study Started
Nov 30
2007
Primary Completion
Jun 30
2008
Study Completion
Oct 31
2008
Last Update
Dec 02
2008
Estimate

Drug Gabapentin

Gabapentin 800 mg one a day up to 30 day

  • Other names: Group-1: Gabapentin Arm

Drug Diclofenac

Diclofenac 75 mg one a day up to 30 day

  • Other names: Group-2: Diclofenac arm

1 Active Comparator

Gabapentin

2 Active Comparator

Diclofenac

Criteria 

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
No Results Posted