drugset / Trial / NCT00679614

Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery

NCT00679614

RandomizedParallel-groupDouble-blindTreatment

Summary

Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period. The primary objective is to determine opioid use during combined use of oral tramacet and naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective knee/ hip arthroplasty under spinal anesthesia. Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of independent mobilization. Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction in opioid use and reduced opioid-induced side effects.

Timeline

Start
2007-12-17
Primary completion
2011-05-31
Completion
2011-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 1 g Oral
Subject Naloxone Small molecule 0.25 ug/kg
Subject tramacet Unknown Oral

Indications

No indication recorded.