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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionChest Pain
Paresthesia
InterventionDrug: Gabapentin
Drug: Diclofenac
PhasePhase 4
SponsorUsak State Hospital
Responsible PartyUsak State Hospital
ClinicalTrials.gov IdentifierNCT00800527
First ReceivedNovember 28, 2008
Last UpdatedDecember 1, 2008
Last verifiedNovember 2008

Tracking Information[ + expand ][ + ]

First Received DateNovember 28, 2008
Last Updated DateDecember 1, 2008
Start DateNovember 2007
Estimated Primary Completion DateOctober 2008
Current Primary Outcome MeasuresReduction of pain or paresthesia severity [Time Frame: one month] [Designated as safety issue: No]
Current Secondary Outcome Measuresduration of relief of pain or paresthesia [Time Frame: three month] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Official TitlePhase 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 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.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Chest Pain
  • Paresthesia
InterventionDrug: Gabapentin
Gabapentin 800 mg one a day up to 30 day
Other Names:
Group-1: Gabapentin ArmDrug: Diclofenac
Diclofenac 75 mg one a day up to 30 day
Other Names:
Group-2: Diclofenac arm
Study Arm (s)
  • Active Comparator: 1
    Gabapentin
  • Active Comparator: 2
    Diclofenac

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment110
Estimated Completion DateOctober 2008
Estimated Primary Completion DateJune 2008
Eligibility 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
GenderBoth
Ages15 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesTurkey

Administrative Information[ + expand ][ + ]

NCT Number NCT00800527
Other Study ID NumbersB4ISM4350015-009/295
Has Data Monitoring CommitteeNo
Information Provided ByUsak State Hospital
Study SponsorUsak State Hospital
CollaboratorsNot Provided
Investigators Principal Investigator: Ismail BIYIK, MD Investigator
Verification DateNovember 2008

Locations[ + expand ][ + ]

Usak State Hospital
Usak, Turkey, 64100