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Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT00485433•Pacira Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.
+5 more criteria

Locations (7)

Arcadia Methodist Hospital

Arcadia, California, United States

Saddleback Valley Outpatient Surgery

Laguna Hills, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

St. Luke's Roosevelt Hosptial Center

New York, New York, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Memorial Hermann Healthcare System

Houston, Texas, United States

Kirby Outpatient Surgical Center

Houston, Texas, United States

Key Dates

Start Date

June 1, 2007

Primary Completion Date

December 1, 2007

Completion Date

August 1, 2008

Last Updated

March 2, 2021

Enrollment

ACTUAL participants

Conditions

Postoperative Pain

Interventions

Bupivacaine HCl

DRUG

SKY0402

DRUG

QIPB in Inguinal Hernia

NCT06862609

Postoperative Pain

View study

RECRUITING

Ultrasound-Guided Transversus Abdominis Plane Block Versus Epidural Block for Umbilical Hernia Analgesia

NCT07327463

Umbilical HerniaPostoperative Pain Management

View study

RECRUITINGNA

SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

QIPB in Inguinal Hernia

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SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

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