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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

Memorial Hermann Healthcare System

Houston, Texas, United States, 77024

Kirby Outpatient Surgical Center

Houston, Texas, United States, 77054

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00485433
• Other Study ID Numbers: SKY0402-C-207
• First Posted: June 13, 2007
• Results First Posted: August 6, 2013
• Last Update Posted: March 2, 2021
• Last Verified: February 2021

Keywords provided by Pacira Pharmaceuticals, Inc:

hernia; unilateral; postoperative; analgesia

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal; Epinephrine; Bupivacaine; Anesthetics, Local; Anesthetics; 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; Mydriatics; Sympathomimetics; Vasoconstrictor Agents