A Comparison of the Safety and Effectiveness of Two Forms of Patient-controlled Pain Medication Used After Total Hip Replacement: The E-TRANS Fentanyl Transdermal System Versus the Morphine Intravenous Pump
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Analgesia
Intervention: E-TRANS Fentanyl hydrochloride; Morphine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s): Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA
Summary
The purpose of this study is to compare two pain medications delivered by two different
forms of patient-controlled analgesia (PCA) management systems: the Fentanyl HCl
Patient-Controlled Transdermal System (E-TRANS fentanyl) and the morphine intravenous pump.
Fentanyl HCl and morphine are narcotic pain relievers. The E-TRANS fentanyl system is a
small unit worn on the patient's upper outer arm or chest that uses low-intensity electrical
current to deliver fentanyl through the skin and into the patient's bloodstream. The
patients studied will be those who have just received a total hip replacement.
Clinical Details
Official title: Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by the E-TRANS Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management After Primary Unilateral Total Hip Replacement
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Success (defined by a rating of "Excellent", or "Good") on the 24-hour patient global assessment of the method of pain control.
Secondary outcome: Proportion of successes at 48 and 72 hours and at final assessment; mean pain intensity assessment at 24, 48, and 72 hours and at final assessment; mean scores from the Ramsay Sedation Scale.
Detailed description:
The purpose of this study is to compare two pain medications delivered by two different
forms of patient-controlled analgesia (PCA). PCA is a form of pain management that allows
the patient to control the amount of pain medication he or she receives. The PCA E-TRANS
fentanyl system is a credit card-sized unit that is worn on the patient's upper outer arm or
chest. It uses low-intensity electrical current to move fentanyl through the skin and into
the patient's bloodstream. It does not require the insertion of an intravenous (IV) needle,
or injection for pain management. PCA IV morphine is delivered into a vein by an IV
infusion pump that is specially designed to be controlled by the patient. The PCA E-TRANS
fentanyl system delivers a 40 microgram dose of fentanyl and the PCA IV morphine delivers a
1 milligram intravenous dose of morphine. The patients in this study are those scheduled
for a total hip replacement in one (not both) hips. Before surgery, patients will be taught
how to use both PCA devices and randomly assigned to receive either PCA IV morphine or
E-TRANS fentanyl. After undergoing the hip replacement, patients will have the PCA device
applied to the skin (E-TRANS fentanyl) or an IV inserted into a vein (PCA IV morphine),
according to the random assignment. The patient will then be allowed to control delivery of
the assigned medication for 72 hours. During the first 24 hours, the patient will be asked
about the amount of pain he or she is having. The primary measure of effectiveness is
successful pain relief (defined by a rating of "Excellent", or "Good") on the 24-hour
patient global assessment of the method of pain control. At 24, 48, and 72 hours, the
patient will be asked a set of specific questions to measure the effectiveness of the PCA.
In addition, the patient's doctor, nurses, and physical therapists will answer questions
about the PCA system. Safety will be assessed by monitoring the patient's vital signs and
recording any adverse events, including problems at the location on the patient's body where
the PCA device has been applied or inserted. The objective is to establish that the
Fentanyl HCl Patient-Controlled Transdermal System (E-TRANS fentanyl) is as effective as
intravenous (IV) PCA morphine in controlling pain after a total hip replacement.
E-TRANS fentanyl 40 mcg transdermally per patient-activated dose over 10 minutes, up to 6
doses per hour or a maximum of 80 doses in 24 hours; Patient controlled intravenous morphine
1 mg dose, up to 10 doses per hour or a maximum of 240 doses in 24 hours. Study duration is
72 hours.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with a pre-operative American Society of Anesthesiology Physical Status I,
II, or III (Class I are healthy persons less than 80 years of age, Class II are
patients over age 80 years of age with mild systemic disease, and Class III are
patients with severe and non-incapacitating disease)
- Admitted to the Post-Anesthesia Care Unit after general or spinal anesthesia (using
bupivacaine)
- Surgical time of up to 4 hours for total hip replacement surgery with a single
surgical incision
- Awake and breathing spontaneously, with a respiratory rate of 8 to 24 breaths per
minute and oxygen saturation of 90% or higher (with or without supplemental oxygen)
- Expected to remain hospitalized for at least 24 hours postoperatively
Exclusion Criteria:
- Patients whose post-operative pain would normally be managed with oral or
non-narcotic pain medication
- Who received intraoperative spinal anesthesia other than bupivacaine (without
epinephrine), intraoperative epidural anesthesia, or who are expected to have
postoperative analgesia supplied by a continuous regional technique
- Have a history of allergy, hypersensitivity, or tolerance to fentanyl or morphine, or
a history of allergy or hypersensitivity to cetylpyridinium chloride or skin
adhesives, or have the presence of active skin disease that would interfere with
application of the E-TRANS fentanyl system
- Who received systemic or intra-articular steroids within 1 month before surgery or
during surgery
- Expected to require intensive care postoperatively or who will probably need
additional surgical procedures within 72 hours
Locations and Contacts
Additional Information
Comparison of the Safety and Efficacy of Patient Controlled Analgesia Delivered by Fentanyl HCl Transdermal System Versus Morphine IV Pump for Pain Management after Primary Unilateral Total Hip Replacement
Starting date: March 2004
Last updated: May 18, 2011
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