Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00485433
First received: June 11, 2007
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.


Condition Intervention Phase
Postoperative Pain
Drug: Bupivacaine HCl
Drug: SKY0402
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours [ Time Frame: 0 to 72 hours ] [ Designated as safety issue: No ]
    The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"


Secondary Outcome Measures:
  • Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: June 2007
Study Completion Date: August 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine HCl 105mg
Bupivacaine HCl given during hernia repair
Drug: Bupivacaine HCl
Bupivacaine HCl given during hernia repair
Other Name: Marcaine 0.25% with epinephrine 1:200,000
Experimental: SKY0402 low dose
SKY0402 low dose given during hernia repair
Drug: SKY0402
SKY0402 given during hernia repair
Other Name: EXPAREL
Experimental: SKY0402 Middle dose
SKY0402 middle dose given during hernia repair
Drug: SKY0402
SKY0402 given during hernia repair
Other Name: EXPAREL
Experimental: SKY0402 High dose
SKY0402 high dose given during hernia repair
Drug: SKY0402
SKY0402 given during hernia repair
Other Name: EXPAREL

Detailed Description:

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males 18 years of age and older at the Screening Visit.
  2. Scheduled to undergo, elective, primary, unilateral, open-technique, tension-free (Lichtenstein-type technique with mesh) inguinal hernia repair under general anesthesia.
  3. American Society of Anesthesiology (ASA) Physical Class 1-3.
  4. Capable and willing to comply with all study visits and procedures and to provide written informed consent.
  5. Able to speak, read, and understand the language of the informed consent form, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.

Exclusion Criteria:

  1. Use of any of the following medications within the times specified before surgery:

    • Long-acting opioid medication within 3 days.
    • Any opioid medication within 24 hours.
  2. Concurrent painful physical condition that may require analgesic treatment in the postoperative period for pain that is not strictly related to the hernia repair procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, neuropathic pain, concomitant vasectomy).
  3. Body weight less than 50 kilograms.
  4. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
  5. Other contraindication to bupivacaine.
  6. Contraindication(s) to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.
  7. Contraindication to any of the pain control agents anticipated to be used postoperatively (i.e., acetaminophen or oxycodone).
  8. Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational product, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
  9. Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
  11. Current or historical evidence of any clinically significant condition that, in the opinion of the Investigator, may increase the risk of surgery, complicate the subject's postoperative course, or indicate an increased vulnerability to study drugs and procedures and expose the subject to an unreasonable risk as a result of participating in this clinical trial.

    If during surgery the following criterion is met:

  12. Any clinically significant event or condition uncovered during the hernia repair surgery (e.g., excessive bleeding) that might render the subject medically unstable or complicate the subject's postoperative course.
  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: NCT00485433

Locations
United States, California
Arcadia Methodist Hospital
Arcadia, California, United States, 91007
Saddleback Valley Outpatient Surgery
Laguna Hills, California, United States, 92653
Huntington Memorial Hospital
Pasadena, California, United States, 91105
United States, New York
St. Luke's Roosevelt Hosptial Center
New York, New York, United States, 10025
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Kirby Outpatient Surgical Center
Houston, Texas, United States, 77054
Memorial Hermann Healthcare System
Houston, Texas, United States, 77024
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00485433     History of Changes
Other Study ID Numbers: SKY0402-C-207
Study First Received: June 11, 2007
Results First Received: November 23, 2011
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
hernia
unilateral
postoperative
analgesia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014