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

Phase 3

Completed

• Conditions: Hip Arthroplasty; Knee Arthroplasty; Spinal Anesthesia
• Interventions: Drug: tramacet; Drug: tramacet, naloxone; Drug: Acetaminophen

• Registration Number: NCT00679614
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-16
• Study First Posted: 2008-05-19
• Primary Completion: 2011-05-31
• Study Completion: 2011-05-31
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	tramacet	Group B will receive oral tramacet 2 tablets preoperatively and then 2 tablets every 6 hours for five days. ( or until discharge. Patient VAS after discontinuation of morphine PCA may dictate addition of oral narcotic oxycodone after discharge). This group will also receive saline infusion at 4-6mls / hour for the duration of the hospital stay.
1	tramacet, naloxone	Group A oral tramacet 2 tablets preoperatively, 2 tablets every 6 hours for 5 days then 1-2 tablets of tramacet prn to a maximum of 8 tablets per day. Naloxone infusion starting preop at 0.25ug/kg/hr and continuing during hospital stay (an equivalent of 400ug over 24 hours in a 70 kg man). The infusion will be discontinued 1 hour before patient discharge.
3	Acetaminophen	Group C will receive oral Acetaminophen tablets 1 gm preoperatively and subsequently 6 hourly plus an infusion of saline (placebo) at a rate of 4-6mls / hour for the duration of their stay.

Primary Outcome Measures

Name	Time	Method
Morphine use / day	per day

Trial Locations

Locations (1)

St Joseph's Health Care; 🇨🇦 London, Ontario, Canada