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

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800527
• Other study ID #: B4ISM4350015-009/295
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2008
• Last updated: December 1, 2008
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Usak State Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Paresthesia

Intervention

Drug:
• Gabapentin
Gabapentin 800 mg one a day up to 30 day
• Diclofenac
Diclofenac 75 mg one a day up to 30 day

Locations

Country	Name	City	State
Turkey	Usak State Hospital	Usak

Sponsors (1)

Lead Sponsor	Collaborator
Usak State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain or paresthesia severity		one month	No
Secondary	duration of relief of pain or paresthesia		three month	No