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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00221936
First received: September 20, 2005
Last updated: December 4, 2008
Last verified: July 2005

September 20, 2005
December 4, 2008
July 2004
July 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00221936 on ClinicalTrials.gov Archive Site
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Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Self-Administered Versus Nurse Administered Pain Medication.
Behavioral: Self-administration or nurse administered medication
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00221936
UHN04-0394-AE
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Patti Kastanias, University Health Network
University Health Network, Toronto
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Principal Investigator: Patti Kastanias, RN, MSc(A), ACNP University of Health Network, Toronto
University Health Network, Toronto
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP