Intercostal Nerve Block for Posterolateral Thoracotomy MedDRA version: 14.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865
Conditions
Interventions
Trade Name: EXPAREL®
Product Name: Liposome Bupivacaine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: BUPIVACAINE
CAS Number: 38396-39-3
Current Sponsor code: SKY0402
Concentratio
Sponsors
Pacira Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, =18 years of age. 2. Scheduled to undergo a thoracotomy of at least 3 inches (7.6 cm) of intercostal incisional length or requiring insertion of an inter-rib spreader/retractor for a primary thoracic non-infectious indication under general anesthesia. 3. American Society of Anesthesiologists (ASA) Physical Status 1 - 3. 4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments. 5. Able to demonstrate sensory function by exhibiting sensitivity to cold anywhere within the dermatomes supplied by any of the nerves to which study drug will be administered Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. Female subjects must be surgically sterile, at least 2 years menopausal, or using an acceptable method of birth control. If of childbearing potential, must have a documented negative pregnancy test within 24 hours before surgery. 2. Any planned pleurodesis as part of the surgical procedure. 3. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, NSAID, or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days and any opioid medication within 24 hours. 4. Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) within 3 days of surgery. 5. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the surgery, and which may confound the postsurgical assessments (e.g., cancer pain, chronic neuropathic pain, concurrent abdominal surgery). 6. Current use of systemic glucocorticosteroids within 1 month of enrollment. 7. Body weight < 50 kilograms (110 pounds) or a body mass index = 35 kg/m2. 8. Contraindication to any of the pain-control agents planned for surgical or postsurgical use (i.e., fentanyl, morphine, hydromorphone, oxycodone, or bupivacaine). 9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, 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. 10. Previous participation in a liposome bupivacaine study. 11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 12. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance. 13. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject’s postsurgical course or interfere with the determination of pain intensity related solely to the surgery. 14. Significant medical conditions (including widely disseminated metastatic disease) or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures. 15. Subjects who are planned to receive Entereg® (alvimopan). 16. Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subject's emesis needs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of intercostal nerve block using liposome bupivacaine compared with placebo in subjects undergoing posterolateral thoracotomy.;Secondary Objective: The secondary objectives are to evaluate additional efficacy parameters, assess the PK profile of liposome bupivacaine when administered as an intercostal nerve block, and further characterize the safety profile of liposome bupivacaine.;Primary end point(s): The primary efficacy endpoint is the area under the plasma concentration-time curve (AUC) of the NRS-R pain intensity scores through 72 hours.;Timepoint(s) of evaluation of this end point: Through 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Total postsurgical opioid consumption (in mg) through 72 hours. • Time to first opioid rescue.;Timepoint(s) of evaluation of this end point: - Through 72 hours - Time to first opioid rescue. | — |
Countries
Bulgaria, Czech Republic, Georgia, Poland, United States
Contacts
Public ContactClinical Operations
Pacira Pharmaceuticals, Inc.
Outcome results
None listed