Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01802411
First received: February 26, 2013
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for intercostal nerve block in subjects undergoing posterolateral thoracotomy.


Condition Intervention Phase
Posterolateral Thoracotomy
Postoperative Pain
Drug: Liposome bupivacaine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

Resource links provided by NLM:


Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Scores at Rest for Pain Intensity [ Time Frame: Through 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total postsurgical opioid consumption (mg) [ Time Frame: Through 72 hours ] [ Designated as safety issue: No ]
  • Time to first opioid use [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 191
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liposome bupivacaine
Single total administration of 266 mg (approximately 88 mg to each of three nerve segments) of 6.6 mL volume each for a total of 20 mL.
Drug: Liposome bupivacaine
Placebo Comparator: Placebo
Single total administration of 266 mg (approximately 88 mg to each of three nerve segments) of 6.6 mL volume each for a total of 20 mL
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, ≥18 years of age.
  • 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.
  • American Society of Anesthesiologists (ASA) Physical Status 1 - 3.
  • Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
  • Able to demonstrate sensory function by exhibiting sensitivity to cold in one dermatome area in which study drug will be administered.

Exclusion Criteria:

  • 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.
  • Any planned pleurodesis as part of the surgical procedure.
  • Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drug (NSAID), or aspirin (except for low-dose aspirin used for cardioprotection or acetaminophen/paracetamol) within 3 days and any opioid medication within 24 hours.
  • Use of selective serotonin reuptake inhibitors (SSRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®) within 3 days of surgery.
  • 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).
  • Current use of systemic glucocorticosteroids within 1 month of enrollment.
  • Body weight < 50 kilograms (110 pounds) or a body mass index ≥ 35 kg/m2.
  • Contraindication to any of the pain-control agents planned for surgical or postsurgical use (i.e., fentanyl, morphine, hydromorphone, oxycodone, or bupivacaine).
  • 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.
  • Previous participation in a liposome bupivacaine 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, could interfere with study assessments or compliance.
  • 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.
  • 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.
  • Subjects who are planned to receive Entereg® (alvimopan).
  • Subjects who will receive prophylactic antiemetics or planned postsurgical antiemetics given without regard to the subject's emesis needs.
  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: NCT01802411

Locations
United States, Florida
Jackson Memorial Hospital/University of Miami, 1611 NW 12th Avenue (R-C300)
Miami, Florida, United States, 33136
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Hwy
Shreveport, Louisiana, United States, 71103
United States, North Dakota
Sanford Heart Center 801 Broadway North
Fargo, North Dakota, United States, 58122
United States, Texas
Research Concepts, GP, LLC, 4525 Texas St.
Bellaire, Texas, United States, 77401
UT Southwestern Medical Center, Dept. Cardiovas7726cular & Thoracic Surgery, 5909 Harry Hines Blvd., 9th Fl.
Dallas, Texas, United States, 75390-8879
The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401
Houston, Texas, United States, 77030
United States, Washington
MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Erol Onel, MD Pacira Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01802411     History of Changes
Other Study ID Numbers: 402-C-322
Study First Received: February 26, 2013
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:
liposome bupivacaine
posterolateral thoracotomy
intercostal nerve block
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
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

ClinicalTrials.gov processed this record on July 24, 2014