Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
Primary Purpose
Self-Administered Versus Nurse Administered Pain Medication.
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-administration or nurse administered medication
Sponsored by

About this trial
This is an interventional treatment trial for Self-Administered Versus Nurse Administered Pain Medication.
Eligibility Criteria
Inclusion Criteria: able to read and write English post elective total knee replacement surgery (primary or revision) already on IV PCA age 18-80 able to tolerate oral medication able to physically open a childproof vial independently (including the absence of any significant problems with manual power, dexterity or visual acuity) able and willing to complete Oral PCA flowsheet Exclusion Criteria: history of substance abuse history of sleep apnea episode(s) of confusion, disorientation during this admission episode(s) of respiratory depression during this admission history of major psychiatric disorder pregnancy
Sites / Locations
- Toronto Western Hospital
- University Health Network
- Universtiy Health Network
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00221936
First Posted
September 20, 2005
Last Updated
December 4, 2008
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00221936
Brief Title
Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
Official Title
Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
4. Oversight
5. Study Description
Brief Summary
Patient Centered Care (PCC) is "an approach that consciously adopts the patient's perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary, Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery - even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current standard of practice for post-operative pain management in most acute care hospitals today is intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients prefer IV PCA because it affords them greater control and provides them with better pain relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ; Rawal, 2001), hospitals routinely take control of pain medications away from patients once they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring them pain tablets.
Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA are similar to IV PCA including increased patient satisfaction and better pain control (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint, 1998). At the Toronto Western Hospital, University Health Network, we have successfully implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The purpose of this study is to compare usual nurse administered oral analgesia to PCOA with respect to pain, patient satisfaction, and passive range of knee motion in postoperative total knee replacement patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-Administered Versus Nurse Administered Pain Medication.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Self-administration or nurse administered medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
able to read and write English
post elective total knee replacement surgery (primary or revision)
already on IV PCA
age 18-80
able to tolerate oral medication
able to physically open a childproof vial independently (including the absence of any significant problems with manual power, dexterity or visual acuity)
able and willing to complete Oral PCA flowsheet
Exclusion Criteria:
history of substance abuse
history of sleep apnea
episode(s) of confusion, disorientation during this admission
episode(s) of respiratory depression during this admission
history of major psychiatric disorder pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patti Kastanias, RN, MSc(A), ACNP
Organizational Affiliation
University of Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Universtiy Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
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