Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
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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 |
- Reduction of pain or paresthesia severity [ Time Frame: one month ] [ Designated as safety issue: No ]
- 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 |
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 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:
|
Paresthesia Chest Pain Pain Signs and Symptoms Somatosensory Disorders Sensation Disorders Neurologic Manifestations Nervous System Diseases Diclofenac Gabapentin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013