NCT00665262

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2011

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

April 18, 2008

Last Update Submit

August 25, 2017

Conditions

Arthroplasty

Keywords

analgesiahip arthroplastyknee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • opoid use post knee/hip arthroplasty

    post-op period

Secondary Outcomes (1)

  • incidence of visual analogue scale scores greater than 4

    post-op period

Study Arms (1)

1

EXPERIMENTAL

comibined use of tramacet and naloxone infusion perioperatively

Drug: tramacet

Interventions

tramacetDRUG

2 tablets every 6 hours for 5 days

1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ngozi Imasogie, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Study Start

December 17, 2007

Primary Completion

November 30, 2010

Study Completion

August 12, 2011

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)