Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Primary Purpose
Chest Pain, Paresthesia
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Gabapentin
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Chest Pain focused on measuring sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia
Eligibility 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
Sites / Locations
- Usak State Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Gabapentin
Diclofenac
Outcomes
Primary Outcome Measures
Reduction of pain or paresthesia severity
Secondary Outcome Measures
duration of relief of pain or paresthesia
Full Information
NCT ID
NCT00800527
First Posted
November 28, 2008
Last Updated
December 1, 2008
Sponsor
Usak State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00800527
Brief Title
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Official Title
Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Usak State Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Paresthesia
Keywords
sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Gabapentin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Diclofenac
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Group-1: Gabapentin Arm
Intervention Description
Gabapentin 800 mg one a day up to 30 day
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Group-2: Diclofenac arm
Intervention Description
Diclofenac 75 mg one a day up to 30 day
Primary Outcome Measure Information:
Title
Reduction of pain or paresthesia severity
Time Frame
one month
Secondary Outcome Measure Information:
Title
duration of relief of pain or paresthesia
Time Frame
three month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail BIYIK, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Usak State Hospital
City
Usak
ZIP/Postal Code
64100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
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