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

This study has been completed.
Sponsor:
Information provided by:
Usak State Hospital
ClinicalTrials.gov Identifier:
NCT00800527
First received: November 28, 2008
Last updated: December 1, 2008
Last verified: November 2008
  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.


Condition Intervention Phase
Chest Pain
Paresthesia
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
Gabapentin
Drug: Gabapentin
Gabapentin 800 mg one a day up to 30 day
Other Name: Group-1: Gabapentin Arm
Active Comparator: 2
Diclofenac
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.

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800527

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

No publications provided

Responsible Party: Ismail BIYIK, Investigator
ClinicalTrials.gov 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:
sternotomy
pain
paresthesia
Poststernotomy chest pain
Poststernotomy chest paresthesia

Additional relevant MeSH terms:
Chest Pain
Paresthesia
Pain
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Gabapentin
Diclofenac
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 18, 2014