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Once Daily Gabapentin in the Treatment of Post Amputation Pain

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Status
Sponsorlar
Chicago Anesthesia Pain Specialists

Açar sözlər

Mücərrəd

Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.

Təsvir

Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation from peripheral vascular disease, peripheral neuropathic disease, neoplasm or traumatic events. Even though the cause of PLP remains unclear and the large number of treatments has been suggested, there is no single treatment regimen proving long lasting pain relief for PLP. However Gabapentin is widely used and have been well suggested recently for the treatment of neuropathic pain.

The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin to offer effective pain relief, improvement of sleep function, and decrease problematic side effects related to the peaks and valleys of the drug's short cycle in patients with PLP. Gabapentin has been clearly demonstrated to be effective in neuropathic pain and epilepsy, but as a treatment option for post amputation pain, it has not been tested.

Approximately, 20 patients will be enrolled in the study, after a titration of two weeks a changing in pain intensity and quality of life will be obtained at subsequent visits. We are expected that the accuracy will be of benefit in reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.

Tarixlər

Son Doğrulandı: 08/31/2017
İlk təqdim: 01/23/2013
Təxmini qeydiyyat təqdim edildi: 01/23/2013
İlk Göndərmə: 01/27/2013
Son Yeniləmə Göndərildi: 09/12/2017
Son Yeniləmə Göndərildi: 09/13/2017
Həqiqi Təhsilin Başlama Tarixi: 01/31/2013
Təxmini İlkin Tamamlanma Tarixi: 10/31/2018
Təxmini İşin Tamamlanma Tarixi: 11/30/2018

Vəziyyət və ya xəstəlik

Pain
Quality of Life

Müdaxilə / müalicə

Drug: Gralise

Faza

Faza 3

Qol Qrupları

QolMüdaxilə / müalicə
Other: Gralise
Efficacy of Gralise
Drug: Gralise
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

Inclusion Criteria:

- Subject must have post amputation pain persisting for more than six months.

- Be considered in reasonably good health, in the opinion of the investigator, other than the post amputation pain at the screening visit (based upon the results of the medical and surgical history, vital signs, pulse oximetry and physical examination.

- Be ≥ 18 years of age at the time of screening.

- Female subject are eligible only if all of the following apply:

- Not pregnant ( negative serum pregnancy test at the screening visit);

- Not lactating

- Consented to use barrier contraceptive methods to avoid pregnancy beginning at least 10 days before check -in and continuing throughout the study up to month after the end of the study.

- Voluntarily provide written informed consent.

- Must in the investigator's opinion, to be able to comply with the study procedure.

Exclusion Criteria:

- Hypersensitivity or allergy to gabapentin

- History of co-existing epilepsy or uncontrolled seizure disorder

- Subject is suffering from dementia or any cognitive dysfunction

- Have an uncontrolled or poorly controlled major psychiatric condition (e.g. schizophrenia, major depression) or who have clinically significant anxiety or depression

- Severe cardiopulmonary or liver disease

- Impaired kidney function testing

- Patient receiving hemodialysis

- Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder

- Subjects currently taking anticonvulsants for any reason of treatment

- History of untreated alcohol abuse

- History of gastrointestinal symptoms such as: diarrhea, dyspepsia or gastro duodenal ulcers

- Subjects with history of gastric reduction surgery

- Any other clinically significant condition, or unstable inter-current illness that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of the pain

- Clinically significant of uncontrolled hypo or hypertension

Nəticə

İlkin nəticə tədbirləri

1. Change in Pain Numeric Rating Scale at rest [Visit 1, 2, 3, 4, 5, 6]

Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.

İkincili Nəticə Tədbirləri

1. Change in Pain numeric rating scale at movement. [Visit 1, 2, 3, 4, 5, 6]

Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.

Digər nəticə tədbirləri

1. Modified brief pain inventory (short form) [Visit 1, and visit 5]

Visit 1, baseline; visit 5, eight weeks after visit 1.

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Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası

  • 55 dildə işləyir
  • Elm tərəfindən dəstəklənən bitki mənşəli müalicələr
  • Təsvirə görə otların tanınması
  • İnteraktiv GPS xəritəsi - yerdəki otları etiketləyin (tezliklə)
  • Axtarışınızla əlaqəli elmi nəşrləri oxuyun
  • Təsirlərinə görə dərman bitkilərini axtarın
  • Maraqlarınızı təşkil edin və xəbər araşdırmaları, klinik sınaqlar və patentlər barədə məlumatlı olun

Bir simptom və ya bir xəstəlik yazın və kömək edə biləcək otlar haqqında oxuyun, bir ot yazın və istifadə olunan xəstəliklərə və simptomlara baxın.
* Bütün məlumatlar dərc olunmuş elmi araşdırmalara əsaslanır

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