Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802411
• Other study ID #: 402-C-322
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2021
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Posterolateral Thoracotomy
• Postoperative Pain

Intervention

Drug:
• EXPAREL 266 mg

• Placebo

Locations

Country	Name	City	State
Bulgaria	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
Czechia	Krajska nemocnice Liberec, a.s., Vseobecna chirurgie	Liberec
Czechia	Fakultni nemocnice Olomouc I. chirurgicka klinika	Olomouc
Czechia	Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska	Prague
Georgia	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
Poland	Klinika Chirurgii Klatki Piersiowej, Chirurgii Ogolnej i Onkologicznej Uniwersytecki Szpital Kliniczny	Lódz
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	Warszawa
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego UM w Katowicach Klinika Anestezjologii i Intensywnej Terapii	Zabrze
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	Sanford Heart Center 801 Broadway North	Fargo	North Dakota
United States	The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401	Houston	Texas
United States	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	MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Georgia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) of Pain Intensity at Rest Through 72 Hours	AUC of pain intensity scores at rest through 72 hours postsurgery. Participants assumed a resting position that did not exacerbate his or her postsurgical pain. Pain intensity scores were measured at baseline and 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours postsurgery, at first request for rescue pain medication, and on day 12 using the numeric rating scale at rest (NRS-R; 0=no pain and 10=worst possible pain).	0-72 hours postsurgery
Secondary	Total Postsurgical Opioid Consumption Through 72 Hours	Total postsurgical opioid consumption (morphine equivalent) through 72 hours postsurgery	0-72 hours postsurgery
Secondary	Time to First Opioid Rescue Through 72 Hours Postsurgery	Time to first use of opioid rescue medication through 72 hours postsurgery, calculated as the date and time of first opioid use minus the date and time of the end of surgery.	72 hours postsurgery