Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

NCT01802411 | Completed Phase 3 Results DMC

• 1 other identifier: 402-C-322
• Study Type: interventional
• Target: 191
• Locations: 5 countries
• Sites: 21

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

Keywords

liposome bupivacaine; posterolateral thoracotomy; intercostal nerve block; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total Postsurgical Opioid Consumption Through 72 Hours

  0-72 hours postsurgery

• Time to First Opioid Rescue Through 72 Hours Postsurgery

  72 hours postsurgery

Study Arms (2)

EXPAREL 266 mg

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EXPAREL 266 mg DRUG

EXPAREL 266 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (21)

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

Miami, Florida, 33136, United States

Location

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

Shreveport, Louisiana, 71103, United States

Location

Sanford Heart Center 801 Broadway North

Fargo, North Dakota, 58122, United States

Location

Research Concepts, GP, LLC, 4525 Texas St.

Bellaire, Texas, 77401, United States

Location

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

Dallas, Texas, 75390-8879, United States

Location

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

Houston, Texas, 77030, United States

Location

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

Tacoma, Washington, 98405, United States

Location

Thoracic Surgery Clinic, SHATPulmD 'Sveta Sofia'

Plovdiv, Bulgaria

Location

Department of surgery with activity in thoracic surgery

Sofia, Bulgaria

Location

Military Medical Academy

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

Krajska nemocnice Liberec, a.s., Vseobecna chirurgie

Liberec, Czechia

Location

Fakultni nemocnice Olomouc I. chirurgicka klinika

Olomouc, Czechia

Location

Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska

Prague, Czechia

Location

Amtel Hospital First Clinical' LLC

Tbilisi, Georgia

Location

Jsc 'National Center for Tuberculosis and Lung Diseases'/

Tbilisi, Georgia

Location

Jsc 'National Center for Tuberculosis and Lung Diseases'

Tbilisi, Georgia

Location

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

Lodz, Poland

Location

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

Szczecin, Poland

Location

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

Warsaw, Poland

Location

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

Zabrze, Poland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Study drug delivery to the intercostal nerve via instillation, not US-guided injection, likely prevented optimal placement/retention, as supported by pharmacokinetic data. Thus, efficacy of study drug as regional nerve block could not be meaningfully evaluated.

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@pacira.com

Pacira Pharmaceuticals, Inc.

Study Officials

• Erol Onel, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 1, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 12, 2021
• Results First Posted: December 9, 2020

Record last verified: 2021-07

Locations

PL (4); CZ (3); US (7); GE (3); BU (4)