Phase 3
N=57
Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients
Non Small Cell Lung Cancer · Lung Cancer Stage 1
Bottom Line
View on ClinicalTrials.gov: NCT03682224 ↗Enrolled (actual)
57
Serious AEs
42.0%
Results posted
Jan 2023
Primary outcome: Primary: Total Morphine Equivalents Consumed — 48; 42.7 MEq
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal Bupivacaine (Drug); Bupivacaine-Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern Illinois University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Morphine Equivalents Consumed |
48; 42.7 | — |
| SECONDARY VAS Pain Score |
4.8; 5.2 | — |
| SECONDARY Treatment Cost |
22,775; 20,252 | — |
| SECONDARY Pharmacy Cost |
1052; 596 | — |
| SECONDARY Mortality |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
- Unable to follow protocol directions due to organic brain or psychiatric disease.
- History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
Data sourced from ClinicalTrials.gov (NCT03682224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.