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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00800527
Enrollment
110
Registered
2008-12-02
Start date
2007-11-30
Completion date
2008-10-31
Last updated
2008-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Paresthesia

Keywords

sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia

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.

Interventions

DRUGGabapentin

Gabapentin 800 mg one a day up to 30 day

DRUGDiclofenac

Diclofenac 75 mg one a day up to 30 day

Sponsors

Usak State Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction of pain or paresthesia severityone month

Secondary

MeasureTime frame
duration of relief of pain or paresthesiathree month

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026