Clinical trial NCT01802411: Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Posterolateral Thoracotomy
Postoperative Pain
Keywords: liposome bupivacaine
posterolateral thoracotomy
intercostal nerve block
postoperative pain
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area Under the Curve (AUC) of Pain Intensity at Rest Through 72 Hours
timeFrame: 0-72 hours postsurgery
Secondary outcomes:
measure: Total Postsurgical Opioid Consumption Through 72 Hours
timeFrame: 0-72 hours postsurgery
measure: Time to First Opioid Rescue Through 72 Hours Postsurgery
timeFrame: 72 hours postsurgery
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital/University of Miami, 1611 NW 12th Avenue (R-C300)
state: Florida
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Hwy
state: Louisiana
city: Fargo
country: United States
facility: Sanford Heart Center 801 Broadway North
state: North Dakota
city: Bellaire
country: United States
facility: Research Concepts, GP, LLC, 4525 Texas St.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center, Dept. Cardiovas7726cular & Thoracic Surgery, 5909 Harry Hines Blvd., 9th Fl.
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401
state: Texas
city: Tacoma
country: United States
facility: MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way
state: Washington
city: Plovdiv
country: Bulgaria
facility: Thoracic Surgery Clinic, SHATPulmD 'Sveta Sofia'
city: Sofia
country: Bulgaria
facility: Department of surgery with activity in thoracic surgery
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospiatl for Active Treatment and Emergency Medicine 'Pirogov'
city: Liberec
country: Czechia
facility: Krajska nemocnice Liberec, a.s., Vseobecna chirurgie
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc I. chirurgicka klinika
city: Prague
country: Czechia
facility: Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska
city: Tbilisi
country: Georgia
facility: Amtel Hospital First Clinical' LLC
city: Tbilisi
country: Georgia
facility: Jsc 'National Center for Tuberculosis and Lung Diseases'/
city: Tbilisi
country: Georgia
facility: Jsc 'National Center for Tuberculosis and Lung Diseases'
city: Szczecin
country: Poland
facility: Klinika Chirurgii Klatki Piersiowej Pomorskiego Uniwersytetu Medycznego w Szczecinie Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego
city: Warszawa
country: Poland
facility: Oddzial Zabiegowy Kliniki Nowotworow Pluca i Klatki Piersiowej Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego UM w Katowicach Klinika Anestezjologii i Intensywnej Terapii
city: Łódź
country: Poland
facility: Klinika Chirurgii Klatki Piersiowej, Chirurgii Ogolnej i Onkologicznej Uniwersytecki Szpital Kliniczny
Study officials:
affiliation: Pacira Pharmaceuticals, Inc
name: Erol Onel, MD
role: STUDY_DIRECTOR
References: