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

NCT ID: NCT00800527

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-10-31

Brief Summary

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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

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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

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Chest Pain Paresthesia

Keywords

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sternotomy pain paresthesia Poststernotomy chest pain Poststernotomy chest paresthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Gabapentin 800 mg one a day up to 30 day

2

Diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Diclofenac 75 mg one a day up to 30 day

Interventions

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Gabapentin

Gabapentin 800 mg one a day up to 30 day

Intervention Type DRUG

Diclofenac

Diclofenac 75 mg one a day up to 30 day

Intervention Type DRUG

Other Intervention Names

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Group-1: Gabapentin Arm Group-2: Diclofenac arm

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Usak State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Investigator

Principal Investigators

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Ismail BIYIK, MD

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

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Usak State Hospital

Uşak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B4ISM4350015-009/295

Identifier Type: -

Identifier Source: org_study_id