Clinical trial NCT00221936: 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
Overall status: COMPLETED
Phase: NA
Conditions: Self-Administered Versus Nurse Administered Pain Medication.
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Universtiy Health Network
state: Ontario
Study officials:
affiliation: University of Health Network, Toronto
name: Patti Kastanias, RN, MSc(A), ACNP
role: PRINCIPAL_INVESTIGATOR
References: