Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Posterolateral Thoracotomy
• Intervention / Treatment: Drug: Placebo; Drug: EXPAREL 266 mg

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria
    • Thoracic Surgery Clinic, SHATPulmD 'Sveta Sofia'
  • Sofia, Bulgaria
    • Military Medical Academy
  • Sofia, Bulgaria
    • Department of surgery with activity in thoracic surgery
  • Sofia, Bulgaria
    • University Multiprofile Hospiatl for Active Treatment and Emergency Medicine 'Pirogov'
• Czechia
  • Liberec, Czechia
    • Krajska nemocnice Liberec, a.s., Vseobecna chirurgie
  • Olomouc, Czechia
    • Fakultni nemocnice Olomouc I. chirurgicka klinika
  • Prague, Czechia
    • Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska
• Georgia
  • Tbilisi, 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'
• Poland
  • Szczecin, Poland
    • Klinika Chirurgii Klatki Piersiowej Pomorskiego Uniwersytetu Medycznego w Szczecinie Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego
  • Warszawa, Poland
    • Oddzial Zabiegowy Kliniki Nowotworow Pluca i Klatki Piersiowej Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
  • Zabrze, Poland
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego UM w Katowicach Klinika Anestezjologii i Intensywnej Terapii
  • Łódź, Poland
    • Klinika Chirurgii Klatki Piersiowej, Chirurgii Ogolnej i Onkologicznej Uniwersytecki Szpital Kliniczny
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital/University of Miami, 1611 NW 12th Avenue (R-C300)
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Hwy
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Heart Center 801 Broadway North
  • Texas
    • Bellaire, Texas, United States, 77401
      • Research Concepts, GP, LLC, 4525 Texas St.
    • Dallas, Texas, United States, 75390-8879
      • UT Southwestern Medical Center, Dept. Cardiovas7726cular & Thoracic Surgery, 5909 Harry Hines Blvd., 9th Fl.
    • Houston, Texas, United States, 77030
      • The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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)	Drug: EXPAREL 266 mg
PLACEBO_COMPARATOR: Placebo; Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments)	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postsurgical Opioid Consumption Through 72 Hours	Total postsurgical opioid consumption (morphine equivalent) through 72 hours postsurgery	0-72 hours postsurgery
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

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (ESTIMATE): March 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: postoperative pain; intercostal nerve block; liposome bupivacaine; posterolateral thoracotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 402-C-322