Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients

NCT03682224 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CRABTREE-18-185
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain control and to see which one helps decrease the need for opioid medications. Participants will receive either Marcaine (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the drug will be chosen in a random fashion. Participants will be followed during the hospital stay and for one year thereafter. An visual Scale will be administered to measure pain, and opioid drug use will be measured by calculating morphine equivalent dose on each day post surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits. Participants will be monitored for any drug related toxicity and other co-morbid conditions for a period on one year post surgery. Overall cost for the surgery and during in hospital stay post surgery will be collected and compared between the two treatment arms.

Conditions

Non Small Cell Lung Cancer; Lung Cancer Stage 1

Keywords

clinical trial; bupivacaine-epinephrine; bupivacaine liposome; pain; Morphine equivalent dose; lobectomy; Laproscopic lobectomy; VATS lobectomy; opioid medications

Outcome Measures

Primary Outcomes (1)

• Total Morphine Equivalents Consumed

  Measured as overall intake of any drugs in the opioid class (Morphine Equivalent Dosing)

  up to 72 hours post surgery

Secondary Outcomes (4)

• VAS Pain Score

  In-hospital until discharge, approximately 3 days, will be collected each time before dispensing pain medications

• Treatment Cost

  In-hospital Costs until discharge, approximately 3 days

• Pharmacy Cost

  In-hospital until discharge, approximately 3 days

• Mortality

  Up to 30 days post surgery

Other Outcomes (4)

• Hospital Stay

  Length of hospital stay - from admission to discharge, approximately 3 days

• Pneumothorax

  In-hospital until discharge, approximately 3 days

• Prolonged Air Leak

  > 5 days to 7 days

Study Arms (2)

Exparel

ACTIVE COMPARATOR

Drug: Liposomal Bupivacaine

Marcaine

ACTIVE COMPARATOR

Drug: Bupivacaine-Epinephrine

Interventions

Liposomal Bupivacaine DRUG

Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site

Exparel

Bupivacaine-Epinephrine DRUG

Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site

Marcaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult at least 18 years of age
• Subject needs elective lobectomy for non small cell lung cancer
• Willing to comply with all aspects of protocol, including providing information about opioid usage for post-surgical pain and signed informed consent

You may not qualify if:

• \< 18 years of age, \> 80 years of age
• Inability or unwillingness to consent
• Emergency surgery
• Previous ipsilateral thoracic surgery
• Need for operative pleurectomy or pleurodesis
• Chronic Narcotic use
• Any narcotic use in the 1 month period prior to screening
• Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
• Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the upper limit of normal.
• Severe renal impairment or end stage renal failure disease (creatinine greater than 2.0 mg/dl).
• History of peptic ulcerative disease
• Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction surgery).
• Pregnancy
• Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open thoracotomy
• Subjects who are incarcerated

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Memorial Medical Center, Southern Illinois University-School of Medicine

Springfield, Illinois, 62781, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Pain

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sowmy Thuppal, Research Assistant Professor
• Organization: Southern Illinois University School of Medicine

sthuppal83@siumed.edu

217-545-2320

Study Officials

• Traves Crabtree, MD

  Professor of Surgery

  PRINCIPAL INVESTIGATOR

• Stephen Hazelrigg, MD

  Professor of Surgery

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not be aware of the drug group. A study statistician will generate the randomization with two arms. Statistician will be blinded and will not be aware of the treatment allocation. Researchers and clinicians will be aware of the allocation and drugs will be dispensed by the hospital pharmacy based on the allocation sequence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive either Exparel or Marcaine during surgery. Based on the randomization they will receive one of the two drugs. Participants are assigned one of the two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 24, 2018
• Study Start: July 5, 2018
• Primary Completion: September 3, 2022
• Study Completion: September 3, 2022
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)