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

February 11, 2021 updated by: Pacira Pharmaceuticals, Inc

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine HCl 105mg
Bupivacaine HCl given during hernia repair
Drug: Bupivacaine HCl
Bupivacaine HCl given during hernia repair
Other Names:
  • 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 Names:
  • EXPAREL
Experimental: SKY0402 Middle dose
SKY0402 middle dose given during hernia repair
Drug: SKY0402
SKY0402 given during hernia repair
Other Names:
  • EXPAREL
Experimental: SKY0402 High dose
SKY0402 high dose given during hernia repair
Drug: SKY0402
SKY0402 given during hernia repair
Other Names:
  • EXPAREL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?"
0 to 72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days
Time Frame: Up to 30 days
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacira Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 13, 2007

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKY0402-C-207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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