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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00264485
First received: December 9, 2005
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Analgesia
Drug: E-TRANS Fentanyl hydrochloride; Morphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • Success (defined by a rating of "Excellent", or "Good") on the 24-hour patient global assessment of the method of pain control.

Secondary Outcome Measures:
  • 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.

Enrollment: 799
Study Start Date: March 2004
Study Completion Date: April 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264485

Sponsors and Collaborators
Alza Corporation, DE, USA
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Alza Corporation Clinical Trial Alza Corporation, DE, USA
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00264485     History of Changes
Other Study ID Numbers: CR004720
Study First Received: December 9, 2005
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
Postoperative pain
patient-controlled analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014