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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
Usak State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 28, 2008
Last Updated
December 1, 2008
Sponsor
Usak State Hospital
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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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