Dose Finding Posterolateral Thoracotomy Study

NCT ID: NCT00807209

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-02-28

Brief Summary

To review safety and effectiveness of two doses compared to current standard of care.

Detailed Description

Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Dose SKY0402

Group Type: EXPERIMENTAL

High Dose SKY0402

Intervention Type: DRUG

Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)

Fentanyl via PCA

Intervention Type: DRUG

Fentanyl via PCA

Bupivacaine via epidural

Intervention Type: DRUG

Bupivacaine via epidural

Standard of Care

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)

Fentanyl via PCA

Intervention Type: DRUG

Fentanyl via PCA

Bupivacaine via epidural

Intervention Type: DRUG

Bupivacaine via epidural

Low Dose SKY0402

Group Type: EXPERIMENTAL

Low Dose SKY0402

Intervention Type: DRUG

Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)

Fentanyl via PCA

Intervention Type: DRUG

Fentanyl via PCA

Bupivacaine via epidural

Intervention Type: DRUG

Bupivacaine via epidural

Interventions

Low Dose SKY0402

Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)

Intervention Type: DRUG

High Dose SKY0402

Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)

Intervention Type: DRUG

Placebo

Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)

Intervention Type: DRUG

Fentanyl via PCA

Fentanyl via PCA

Intervention Type: DRUG

Bupivacaine via epidural

Bupivacaine via epidural

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men and women ≥ 18 years of age at the Screening Visit.
• Scheduled to undergo a thoracotomy of at least 3 inches of intercostal incisional length or requiring insertion of an inter-rib spreader/retractor for a primary thoracic non-infectious indication under general anesthesia.
• Able and willing to receive an epidural catheter for the treatment of postoperative pain.
• American Society of Anesthesiology (ASA) Physical Class 1-4.
• Able and willing to comply with all study visits and procedures.
• Able to speak, read, and understand the language of the ICF, 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.
• Willing and capable of providing written informed consent.

Exclusion Criteria

• Known metastatic disease of any type.
• Known pulmonary infectious disease.
• Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
• Use of any of the following medications within the times specified before surgery:

1. Long-acting opioids within 3 days.

2. Any opioid medication within 24 hours.

• Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
• Body weight less than 50 kilograms (110 pounds).
• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.
• Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline 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.
• 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.
• History of, 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 with the protocol.
• Significant medical conditions or laboratory results that, in the opinion of the Investigator, 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, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, sever renal impairment, advanced diabetes, co-morbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kay Warnott, RN, ACN-P

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

Lotus Clinical Research

Pasadena, California, United States

Florida Hospital

Orlando, Florida, United States

Memorial Hermann - Memorial City Medical Center

Houston, Texas, United States

Houston NW Medical Center

Houston, Texas, United States

Multicare Health System

Tacoma, Washington, United States

Countries

United States

Other Identifiers

SKY0402C211

Identifier Type: -

Identifier Source: org_study_id