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

NCT00485433 | Completed Phase 2 Results

• 1 other identifier: SKY0402-C-207
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Postoperative Pain

Keywords

hernia; unilateral; postoperative; analgesia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 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 Outcomes (1)

• Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days

  Up to 30 days

Study Arms (4)

Bupivacaine HCl 105mg

ACTIVE COMPARATOR

Bupivacaine HCl given during hernia repair

Drug: Bupivacaine HCl

SKY0402 low dose

EXPERIMENTAL

SKY0402 low dose given during hernia repair

Drug: SKY0402

SKY0402 Middle dose

EXPERIMENTAL

SKY0402 middle dose given during hernia repair

Drug: SKY0402

SKY0402 High dose

EXPERIMENTAL

SKY0402 high dose given during hernia repair

Drug: SKY0402

Interventions

Bupivacaine HCl DRUG

Bupivacaine HCl given during hernia repair

Also known as: Marcaine 0.25% with epinephrine 1:200,000

Bupivacaine HCl 105mg

SKY0402 DRUG

SKY0402 given during hernia repair

Also known as: EXPAREL

SKY0402 High dose; SKY0402 Middle dose; SKY0402 low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 18 years of age and older at the Screening Visit.
• Scheduled to undergo, elective, primary, unilateral, open-technique, tension-free (Lichtenstein-type technique with mesh) inguinal hernia repair under general anesthesia.
• American Society of Anesthesiology (ASA) Physical Class 1-3.
• Capable and willing to comply with all study visits and procedures and to provide written informed consent.
• 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.

You may not qualify if:

• 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.
• 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).
• Body weight less than 50 kilograms.
• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics.
• Other contraindication to bupivacaine.
• 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.
• Contraindication to any of the pain control agents anticipated to be used postoperatively (i.e., acetaminophen or oxycodone).
• 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.
• Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
• 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:
• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (7)

Arcadia Methodist Hospital

Arcadia, California, 91007, United States

Location

Saddleback Valley Outpatient Surgery

Laguna Hills, California, 92653, United States

Location

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

St. Luke's Roosevelt Hosptial Center

New York, New York, 10025, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Memorial Hermann Healthcare System

Houston, Texas, 77024, United States

Location

Kirby Outpatient Surgical Center

Houston, Texas, 77054, United States

Location

Related Publications (1)

• 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.

  PMID: 22900785 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Hernia; Agnosia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc.

ErolOnel@pacira.com

203-837-6500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: August 1, 2008
• Last Updated: March 2, 2021
• Results First Posted: August 6, 2013

Record last verified: 2021-02

Locations

US (7)