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

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485433
• Other study ID #: SKY0402-C-207
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2021
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Postoperative Pain

Intervention

Drug:
• Bupivacaine HCl
Bupivacaine HCl given during hernia repair
• SKY0402
SKY0402 given during hernia repair

Locations

Country	Name	City	State
United States	Arcadia Methodist Hospital	Arcadia	California
United States	Kirby Outpatient Surgical Center	Houston	Texas
United States	Memorial Hermann Healthcare System	Houston	Texas
United States	Saddleback Valley Outpatient Surgery	Laguna Hills	California
United States	St. Luke's Roosevelt Hosptial Center	New York	New York
United States	Huntington Memorial Hospital	Pasadena	California
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days		Up to 30 days