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

• Status: Completed
• Trial end date: 2011-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Acetaminophen; Morphine; Naloxone; Tramadol

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