Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

NCT ID: NCT01802411

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-06-30

Brief Summary

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

Conditions

Posterolateral Thoracotomy; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EXPAREL 266 mg

Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg \[6.6 mL\] to each of three nerve segments)

Group Type: ACTIVE_COMPARATOR

EXPAREL 266 mg

Intervention Type: DRUG

Placebo

Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

EXPAREL 266 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• 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

Erol Onel, MD

Role: STUDY_DIRECTOR

Pacira Pharmaceuticals, Inc

Locations

Jackson Memorial Hospital/University of Miami, 1611 NW 12th Avenue (R-C300)

Miami, Florida, United States

Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Hwy

Shreveport, Louisiana, United States

Sanford Heart Center 801 Broadway North

Fargo, North Dakota, United States

Research Concepts, GP, LLC, 4525 Texas St.

Bellaire, Texas, United States

UT Southwestern Medical Center, Dept. Cardiovas7726cular & Thoracic Surgery, 5909 Harry Hines Blvd., 9th Fl.

Dallas, Texas, United States

The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401

Houston, Texas, United States

MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way

Tacoma, Washington, United States

Thoracic Surgery Clinic, SHATPulmD 'Sveta Sofia'

Plovdiv, , Bulgaria

Department of surgery with activity in thoracic surgery

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

University Multiprofile Hospiatl for Active Treatment and Emergency Medicine 'Pirogov'

Sofia, , Bulgaria

Krajska nemocnice Liberec, a.s., Vseobecna chirurgie

Liberec, , Czechia

Fakultni nemocnice Olomouc I. chirurgicka klinika

Olomouc, , Czechia

Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska

Prague, , Czechia

Amtel Hospital First Clinical' LLC

Tbilisi, , Georgia

Jsc 'National Center for Tuberculosis and Lung Diseases'/

Tbilisi, , Georgia

Jsc 'National Center for Tuberculosis and Lung Diseases'

Tbilisi, , Georgia

Klinika Chirurgii Klatki Piersiowej, Chirurgii Ogolnej i Onkologicznej Uniwersytecki Szpital Kliniczny

Lodz, , Poland

Klinika Chirurgii Klatki Piersiowej Pomorskiego Uniwersytetu Medycznego w Szczecinie Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego

Szczecin, , Poland

Oddzial Zabiegowy Kliniki Nowotworow Pluca i Klatki Piersiowej Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

Warsaw, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego UM w Katowicach Klinika Anestezjologii i Intensywnej Terapii

Zabrze, , Poland

Countries

United States; Bulgaria; Czechia; Georgia; Poland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

402-C-322

Identifier Type: -

Identifier Source: org_study_id