Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery
Information source: Lawson Health Research Institute
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Arthroplasty; Knee Arthroplasty; Spinal Anesthesia
Intervention: tramacet, naloxone (Drug); tramacet (Drug); Acetaminophen (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Lawson Health Research Institute Overall contact:
Ngozi Imasogie, MBBS, FRCA, Phone: 519-646-6000, Ext: 64219, Email: Ngozi.Imasogie@sjhc.london.on.ca
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.
Clinical Details
Official title: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Randomized Controlled Study.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Primary outcome: Morphine use / day
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Aged 70 years and older*
2. Able to give informed consent
3. Able to communicate in English
4. Having elective hip/knee arthroplasty
5. ASA physical status 1-3.
Exclusion Criteria:
1. Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
2. Contraindication to spinal anesthesia
3. Contraindication to use of tramacet or celebrex
4. ASA physical status 4
5. Chronic opioid use
6. Chronic pain syndrome All the above will be included in the letter of information
Locations and Contacts
Ngozi Imasogie, MBBS, FRCA, Phone: 519-646-6000, Ext: 64219, Email: Ngozi.Imasogie@sjhc.london.on.ca
St Joseph's Health Care, London, Ontario N6A 4V2, Canada
Additional Information
Starting date: September 2008
Ending date: November 2008
Last updated: May 16, 2008
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