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

Phase 4

Completed

• Conditions: Chest Pain; Paresthesia
• Interventions: Drug: Gabapentin; Drug: Diclofenac

• Registration Number: NCT00800527
• Lead Sponsor: Usak State Hospital

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-06
• Study Completion: 2008-10
• Status Verified: 2008-11
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-12-01
• Last Update Submitted: 2008-12-01
• Study First Posted: 2008-12-02
• Last Update Posted: 2008-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gabapentin	Gabapentin
2	Diclofenac	Diclofenac

Primary Outcome Measures

Name	Time	Method
Reduction of pain or paresthesia severity	one month

Secondary Outcome Measures

Name	Time	Method
duration of relief of pain or paresthesia	three month

Trial Locations

Locations (1)

Usak State Hospital; 🇹🇷 Usak, Turkey