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Completed

NCT Number: NCT00800527

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

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.

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Key information

Conditions

Chest Pain Nervous System Diseases Neurologic Manifestations Pain Paresthesia Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Usak State Hospital

Uşak, 64100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin

Drug

Gabapentin 800 mg one a day up to 30 day

Other names: Group-1: Gabapentin Arm

Diclofenac

Drug

Diclofenac 75 mg one a day up to 30 day

Other names: Group-2: Diclofenac arm

Primary outcomes

  1. Reduction of pain or paresthesia severity

    Time frame: one month

Secondary outcomes

  1. duration of relief of pain or paresthesia

    Time frame: three month

Sponsors and collaborators

Lead sponsor

Usak State Hospital

Other

Registry information

Official study title

Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 2, 2008
Registry last updated
Dec 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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