Dose Finding Posterolateral Thoracotomy Study

This study has been terminated.
(Sponsor decision unrelated to safety)
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00807209
First received: December 9, 2008
Last updated: April 15, 2012
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Postoperative Pain
Drug: Low Dose SKY0402
Drug: High Dose SKY0402
Drug: Placebo
Drug: Fentanyl via PCA
Drug: Bupivacaine via epidural
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label, Parallel Group, Randomized, Dose-Finding Study to Assess the Efficacy and Safety of Intercostal SKY0402 in Subjects Undergoing Posterolateral Thoracotomy

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.


Enrollment: 3
Study Start Date: December 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose SKY0402 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)
Drug: Fentanyl via PCA
Fentanyl via PCA
Drug: Bupivacaine via epidural
Bupivacaine via epidural
Active Comparator: Standard of Care 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)
Drug: Fentanyl via PCA
Fentanyl via PCA
Drug: Bupivacaine via epidural
Bupivacaine via epidural
Experimental: Low Dose SKY0402 Drug: 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)
Drug: Fentanyl via PCA
Fentanyl via PCA
Drug: Bupivacaine via epidural
Bupivacaine via epidural

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807209

Locations
United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32801
United States, Texas
Memorial Hermann - Memorial City Medical Center
Houston, Texas, United States, 77024
Houston NW Medical Center
Houston, Texas, United States, 77053
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Kay Warnott, RN, ACN-P Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00807209     History of Changes
Other Study ID Numbers: SKY0402C211
Study First Received: December 9, 2008
Results First Received: November 29, 2011
Last Updated: April 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
Pain
postoperative
thoracotomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 11, 2014