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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485433
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE June 11, 2007
First Posted Date  ICMJE June 13, 2007
Results First Submitted Date  ICMJE November 23, 2011
Results First Posted Date  ICMJE August 6, 2013
Last Update Posted Date August 6, 2013
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
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 ]
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?"
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
Extent and duration of analgesic effect [ Time Frame: Up to 30 days ]
Change History Complete list of historical versions of study NCT00485433 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2011)
Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days [ Time Frame: Up to 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2007)
Confirm the optimal therapeutic dose; Identify the lowest effective dose; Evaluate additional efficacy parameters; Characterize the safety profile of SKY0402 in comparison to bupivacaine HCl [ Time Frame: Up to 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair
Official Title  ICMJE 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.
Brief Summary The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Bupivacaine HCl
    Bupivacaine HCl given during hernia repair
    Other Name: Marcaine 0.25% with epinephrine 1:200,000
  • Drug: SKY0402
    SKY0402 given during hernia repair
    Other Name: EXPAREL
Study Arms  ICMJE
  • Active Comparator: Bupivacaine HCl 105mg
    Bupivacaine HCl given during hernia repair
    Intervention: Drug: Bupivacaine HCl
  • Experimental: SKY0402 low dose
    SKY0402 low dose given during hernia repair
    Intervention: Drug: SKY0402
  • Experimental: SKY0402 Middle dose
    SKY0402 middle dose given during hernia repair
    Intervention: Drug: SKY0402
  • Experimental: SKY0402 High dose
    SKY0402 high dose given during hernia repair
    Intervention: Drug: SKY0402
Publications * Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2010)
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2007)
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00485433
Other Study ID Numbers  ICMJE SKY0402-C-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pacira Pharmaceuticals, Inc
Study Sponsor  ICMJE Pacira Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pacira Pharmaceuticals, Inc
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP