CTRI/2011/05/001714招募中4 期
Comparison of Tramadol 50 mg or 100 mg for Treatment of Postoperative Pain in Patients undergoing Total Hip Replacement or Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subject 18-75 years of age.
- •2.Subject or legal representative has voluntarily signed and dated a written informed consent.
- •3.Female subjects must be of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year) or if of childbearing potential, agree be abstinent or be practicing a highly effective contraceptive method from consent to 30 days after the last dose of study medication.
- •4.Subject is undergoing elective surgery (unilateral TKA or THA).
- •5.Subject is expected and willing to remain hospitalized for a minimum of 48 hours post surgery (duration of treatment and assessment of efficacy).
- •6.Subject meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, 2, or 3.
排除标准
- •1.Subject is expected to receive gabapentin, pregabalin, ketamine or other peri- or postoperative analgesic adjuncts.
- •2.Subject is undergoing bilateral TKA or THA, hemiarthroplasty, or revision arthroplasty.
- •3.Subject has a history of primary or metastatic bone cancer or Paget¡¯s disease.
- •4.Current or historical evidence of any clinically significant disease or condition that might increase the risk of surgery or complicate the subject¡¯s postoperative course.
- •5.Allergy or hypersensitivity to opioids or Tramadol.
- •6.Subject has known physical dependence on opioids, or is routinely taking opioids during the 2 months prior to Screening.
- •7.Current history of chronic opioid use, substance abuse or known active alcohol abuse.
- •8.Subject is taking medications that inhibit CYP2D6 or CYP3A4 or medications that induce CYP2D6 or CYP3A4.
- •9.Subject has taken monoamine oxidase inhibitors within 14 days of surgery.
- •10.Subject has a history of epilepsy or is susceptible to seizures.
- •11.Subject is taking medications that lower the seizure threshold (e.g., selective serotonin reuptake inhibitors, tricyclic antidepressants or anti-psychotic agents).
- •12.Subject has expressed suicide ideation or is considered to be at risk of suicide.
- •13.Subject is morbidly obese or has documented sleep apnea.
- •14.Female subject is pregnant or breastfeeding.
- •15.History of cardiopulmonary, hepatic, neurological or renal disease that may confound the assessments of efficacy or safety.
- •16.Subject has an ALT or AST value 3X ULN at Screening or Baseline.
- •17.Subject has a serum creatinine value of 2.0 mg/dL at Screening or Baseline.
- •18.Subject has a hemoglobin level at Screening or Baseline which, in the judgment of the Investigator, makes him or her not suitable for participation in this study.
研究者
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