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Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221936
First Posted: September 22, 2005
Last Update Posted: December 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose

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.


Condition Intervention
Self-Administered Versus Nurse Administered Pain Medication. Behavioral: Self-administration or nurse administered medication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Estimated Enrollment: 50
Study Start Date: July 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221936


Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Universtiy Health Network
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Patti Kastanias, RN, MSc(A), ACNP University of Health Network, Toronto
  More Information

Responsible Party: Patti Kastanias, University Health Network
ClinicalTrials.gov Identifier: NCT00221936     History of Changes
Other Study ID Numbers: UHN04-0394-AE
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: December 5, 2008
Last Verified: July 2005

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms