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

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ClinicalTrials.gov Identifier: NCT00485433
Recruitment Status : Completed
First Posted : June 13, 2007
Results First Posted : August 6, 2013
Last Update Posted : March 2, 2021
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Bupivacaine HCl Drug: SKY0402 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
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.
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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?"

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days [ Time Frame: Up to 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485433

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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
Memorial Hermann Healthcare System
Houston, Texas, United States, 77024
Kirby Outpatient Surgical Center
Houston, Texas, United States, 77054
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00485433    
Other Study ID Numbers: SKY0402-C-207
First Posted: June 13, 2007    Key Record Dates
Results First Posted: August 6, 2013
Last Update Posted: March 2, 2021
Last Verified: February 2021
Keywords provided by Pacira Pharmaceuticals, Inc:
Additional relevant MeSH terms:
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Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents