Abstract ID: A22

Abstract Title: Ease of Care of Postoperative Pain Management Following Total Hip Replacement: Fentanyl HCl Patient-controlled Transdermal System (PCTS) versus Morphine Intravenous Patient-controlled Analgesia (IV PCA)

Authors: Phillips S¹, Vallow S², Gargiulo K³, Hewitt D⁴
Arizona Research Center, Phoenix Phoenix AZ
Poster Type: Either

ABSTRACT BODY

Introduction: Intravenous patient-controlled analgesia (IV PCA) with morphine is commonly used to manage acute postoperative pain. Patients prefer IV PCA to conventional analgesic modalities because it provides them the control to dose to comfort, but several drawbacks exist. Patient mobility may be restricted by patient attachment to an IV line, pole, and PCA pump, which may interfere with physical therapy. Administration of IV PCA also requires substantial staff time and resources for IV PCA-related tasks. A recent phase IIIb trial compared the efficacy and safety of a novel, needle-free, self-contained, iontophoretic fentanyl HCl patient-controlled transdermal system (fentanyl HCl PCTS; IONSYS™, Ortho-McNeil Pharmaceutical, Raritan, NJ) with those of an IV PCA with morphine for acute postoperative pain management in patients undergoing total hip replacement surgery. The current analysis of that study evaluated the relative convenience and ease of use of the 2 modalities from the perspective of the patient, nurse, and physical therapist.

Materials and Methods: This was a randomized, multicenter (N=52 sites), open-label, US phase IIIb trial of patients who received IONSYS (n=395) or morphine IV PCA (n=404) following unilateral total hip-replacement surgery. Patients were titrated to comfort with IV opioids and randomized 1:1 to receive IONSYS (40-μg on-demand dose [10-minute infusion]; 6 doses/hour maximum) or IV PCA morphine (1-mg bolus dose; 5-minute lockout period; 10 doses/hour maximum) for up to 72 hours. Ease of care was evaluated as a secondary efficacy endpoint using validated Ease-of-Care (EOC) questionnaires completed by the patient, nurse, or physical therapist (response scales, 0=“not at all” to 5=“a very great deal” on the EOC subscales and 0=“extremely dissatisfied” to 5=“extremely satisfied” on the satisfaction subscale). EOC questionnaires were completed at 72 hours or upon study withdrawal (patients), following study completion at the respective sites(nurses), or after each therapy session (physical therapists). Higher patient scores and lower nurse and physical therapist scores indicated better ease of care. Between-group comparisons were performed using ANOVA (patient), paired t-test (nurse), and mixed-model (physical therapist) approaches.

Results: Patients, nurses, and physical therapists reported significantly better overall EOC scores with IONSYS than with morphine IV PCA (P<0.0001). Mean patient responses were significantly better (P<0.05) for IONSYS than morphine IV PCA on all EOC subscales (Confidence With Device, Comfort With Device, Mobility, Dosing Confidence, Pain Control, and Knowledge/Understanding). Nurses and physical therapists also reported better mean subscale scores (Time-consuming and Bothersome) for IONSYS than morphine IV PCA (P<0.0001 for all). In addition, satisfaction scores indicated significantly greater satisfaction with IONSYS than with morphine IV PCA across patients, nurses, and physical therapists (P<0.001).

Conclusions: Results suggest that IONSYS is easier to use than morphine IV PCA for acute pain management following total hip replacement from the perspective of patients, nurses, and physical therapists.

Acknowledgments: Supported by Ortho-McNeil, Inc.

ATTACHED FILES

Reg Anesth Pain Med 2005; 30(3):A22