A Phase 1/2 interventional study of Bupivacaine liposome and Bupivacaine / Epinephrine in Pain, Postoperative and Lung Cancer, sponsored by University of Tennessee. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.
Sponsored by University of Tennessee · Phase 1/2, Interventional, and Treatment
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 50 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery
Exclusion Criteria:
Patients will receive intraoperative intercostal nerve block with bupivacaine
Drug: Bupivacaine / Epinephrine
Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine
Drug: Bupivacaine liposome
Postoperative pain
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.
Time frame: 3-5 days post op
Postoperative complications
Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.
Time frame: 90 days post op
Narcotic used
Amount of morphine equivalent dosage used in the postoperative period
Time frame: 3-5 days post op
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of Tennessee