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

Study Overview
=================
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.

Official Title
-----------------
Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy

Conditions
-----------------
Chest Pain, Paresthesia

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: Diclofenac


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gabapentin | Drug: Gabapentin<br>* Gabapentin 800 mg one a day up to 30 day<br>* Other names: Group-1: Gabapentin Arm;|
| Active Comparator: 2<br>Diclofenac | Drug: Diclofenac<br>* Diclofenac 75 mg one a day up to 30 day<br>* Other names: Group-2: Diclofenac arm;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain or paresthesia severity |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of relief of pain or paresthesia |  | three month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia