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NCT00665262 Clinical Trial

The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly

Arthroplasty Clinical Trial

Official title:
The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Prospective Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00665262
Other study ID # R-06-159
Secondary ID 12177
Status Completed
Phase Phase 4
First received April 18, 2008
Last updated August 25, 2017
Start date December 17, 2007
Est. completion date August 12, 2011

Study information
Verified date August 2017
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ten patients 70 years and older having elective total hip/knee replacement surgery will be recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia. Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length of stay.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 12, 2011
Est. primary completion date November 30, 2010
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- aged 70 years or older able to give consent able to communicate in English having elective hip/knee arthroplasty ASA physical status 1-3

Exclusion Criteria:

- allergies to any of the following: naloxone, tramacet, NSAIDs, sulpha, or local anesthesic contraindication to spinal anesthesia contraindication to use of tramacet or celebrex ASA physical status4 chronic opiod use chronic pain syndrome

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• tramacet
2 tablets every 6 hours for 5 days

Locations
Country Name City State
Canada St. Joseph's Health Care London Ontario

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary opoid use post knee/hip arthroplasty post-op period
Secondary incidence of visual analogue scale scores greater than 4 post-op period
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