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Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01802411•Pacira Pharmaceuticals, Inc

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (21)

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

Key Dates

Start Date

December 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

July 12, 2021

Enrollment

191

ACTUAL participants

Conditions

Posterolateral ThoracotomyPostoperative Pain

Interventions

EXPAREL 266 mg

DRUG

Placebo

DRUG

QIPB in Inguinal Hernia

NCT06862609

Postoperative Pain

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RECRUITINGNA

SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

NCT07436806

Chronic Post-thoracotomy PainNeuropathic Pain+1 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intercostal Nerve Block With Liposome Bupivacaine in Subjects Undergoing Posterolateral Thoracotomy

Inclusion Criteria

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