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Completed

NCT Number: NCT00221936

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-administration or nurse administered medication

Behavioral

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Patient Controlled Oral Analgesia (PCOA) for Postoperative Pain Management After Total Knee Replacement-A Pilot Study

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Dec 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.