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CompletedNCT00221936Updated Dec 5, 2008

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

An interventional study of Self-administration or nurse administered medication in Self-Administered Versus Nurse Administered Pain Medication., sponsored by University Health Network, Toronto. Completed at 3 sites in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-12-05.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Self-Administered Versus Nurse Administered Pain Medication.

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • BehavioralSelf-administration or nurse administered medication
06

Study locations

3 sites
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
  • University Health Network
    Toronto, Ontario M5T 2S8, Canada
  • Universtiy Health Network
    Toronto, Ontario M5T 2S8, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00221936
Lead sponsor
University Health Network, Toronto
First posted
Sep 22, 2005
Start date
Jul 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Dec 5, 2008

Study contacts

Patti Kastanias, RN, MSc(A), ACNP
principal investigator · University of Health Network, Toronto
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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