Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients

• Status: Active, not recruiting
• Trial end date: 2022-09-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southern Illinois University
• Treatments: Bupivacaine; Epinephrine

Criteria

Inclusion Criteria:

1. Adult at least 18 years of age

2. Subject needs elective lobectomy for non small cell lung cancer

3. Willing to comply with all aspects of protocol, including providing information about opioid usage for post-surgical pain and signed informed consent

Exclusion Criteria:

1. < 18 years of age, > 80 years of age

2. Inability or unwillingness to consent

3. Emergency surgery

4. Previous ipsilateral thoracic surgery

5. Need for operative pleurectomy or pleurodesis

6. Chronic Narcotic use

7. Any narcotic use in the 1 month period prior to screening

8. Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen

9. Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the upper limit of normal.

10. Severe renal impairment or end stage renal failure disease (creatinine greater than 2.0 mg/dl).

11. History of peptic ulcerative disease

12. Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction surgery).

13. Pregnancy

14. Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open thoracotomy

15. Subjects who are incarcerated

16. Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives. Or subject is current enrolled in another clinical trial.

17. Unable to follow protocol directions due to organic brain or psychiatric disease.

18. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.