Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Eduard Shaykhinurov, MS
- Phone Number: 2022038960
- Email: eshaykhinurov@mfa.gwu.edu
Study Locations
-
-
District of Columbia
-
Washington D.C., District of Columbia, United States, 20037
- Recruiting
- The George Washington University Hospital
-
Contact:
- Eduard Shaykhinurov
- Phone Number: 202-203-8960
- Email: eshaykhinurov@mfa.gwu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Video assisted pulmonary resection, pleurodesis or decortication
Exclusion Criteria:
- Allergy to local anesthetics
- Patient undergoing bilateral surgery
- Surgery is emergent as deemed by the principal investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Preoperative Erector Spinae Block (ESB)(Bupivacaine)(Marcaine®)
|
preoperative erector spinae block with bupivacaine (Marcaine®)
intraoperative intercostal nerve block with liposomal bupivacaine (Exparel®)
|
|
Active Comparator: Intraoperative Intercostal Nerve Block (INB)(Liposomal Bupivacaine)(Exparel®)
|
preoperative erector spinae block with bupivacaine (Marcaine®)
intraoperative intercostal nerve block with liposomal bupivacaine (Exparel®)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain control assessment
Time Frame: Up to 48 hours postoperatively
|
Study team will assess postoperative pain scores at 6, 12, 24 and 48 hours (Minimum numerical pain score of 0 and a maximum of 10)
|
Up to 48 hours postoperatively
|
|
Morphine equivalent assessment
Time Frame: Up to 72 hours postoperatively
|
Study team will collect information on all administered pain medications to calculate morphine equivalents
|
Up to 72 hours postoperatively
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain control assessment
Time Frame: Up to 72 hours postoperatively
|
Study team will assess postoperative pain scores at 72 hours (Minimum numerical pain score of 0 and a maximum of 10)
|
Up to 72 hours postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Behavioral Disciplines and Activities
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Dentistry
- Dental Physiological Phenomena
- Bupivacaine
- Dental Occlusion
- Parapsychology
Other Study ID Numbers
Other Study ID Numbers
- NCR246143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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