Trial record 1 of 277 for:    Paresthesia
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Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

This study has been completed.
Information provided by:
Usak State Hospital Identifier:
First received: November 28, 2008
Last updated: December 1, 2008
Last verified: November 2008
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.

Condition Intervention Phase
Chest Pain
Drug: Gabapentin
Drug: Diclofenac
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Resource links provided by NLM:

Further study details as provided by Usak State Hospital:

Primary Outcome Measures:
  • Reduction of pain or paresthesia severity [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of relief of pain or paresthesia [ Time Frame: three month ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Gabapentin
Gabapentin 800 mg one a day up to 30 day
Other Name: Group-1: Gabapentin Arm
Active Comparator: 2
Drug: Diclofenac
Diclofenac 75 mg one a day up to 30 day
Other Name: Group-2: Diclofenac arm

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.

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00800527

Usak State Hospital
Usak, Turkey, 64100
Sponsors and Collaborators
Usak State Hospital
Principal Investigator: Ismail BIYIK, MD Investigator
  More Information

Responsible Party: Ismail BIYIK, Investigator Identifier: NCT00800527     History of Changes
Other Study ID Numbers: B4ISM4350015-009/295 
Study First Received: November 28, 2008
Last Updated: December 1, 2008
Health Authority: Turkey: Ministry of Health

Keywords provided by Usak State Hospital:
Poststernotomy chest pain
Poststernotomy chest paresthesia

Additional relevant MeSH terms:
Chest Pain
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Analgesics, Non-Narcotic
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimanic Agents
Antiparkinson Agents
Antirheumatic Agents
Calcium Channel Blockers
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents processed this record on May 24, 2016