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

NCT ID: NCT00221936

Last Updated: 2008-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-07-31

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.

Conditions

Self-Administered Versus Nurse Administered Pain Medication.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Self-administration or nurse administered medication

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

University Health Network

Principal Investigators

Patti Kastanias, RN, MSc(A), ACNP

Role: PRINCIPAL_INVESTIGATOR

University of Health Network, Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Universtiy Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN04-0394-AE

Identifier Type: -

Identifier Source: org_study_id