To compare pain relief by 2 doses of Tramadol (50 mg or 100 mg) when given for pain relief after knee or hip surgery.
- Conditions
- Health Condition 1: null- Patients who are undergoing elective hip or knee replacement surgery and Tramadol is routinely given intravenously as part of standard pain management.
- Registration Number
- CTRI/2011/05/001714
- Lead Sponsor
- Medanta The Medicity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time to perceptible pain relief in minutes from first dose of Tramadol. <br/ ><br>2.Time to first demand for rescue medication. <br/ ><br>Timepoint: 1.Time to perceptible pain relief in minutes from first dose of Tramadol. <br/ ><br>2.Time to first demand for rescue medication. <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Tolerability of two different doses of Tramadol and correlation of doses, tolerability and efficacy with BMITimepoint: NA