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Trial Title:
Erector Spinae Block for Thoracic Surgery
NCT ID:
NCT05521789
Condition:
Pulmonary Neoplasm
Pulmonary Cancer
Thoracic Diseases
Thoracic Cancer
Thoracic Neoplasms
Conditions: Official terms:
Neoplasms
Thoracic Neoplasms
Lung Neoplasms
Thoracic Diseases
Aortic Dissection
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ESB Thoracic
Description:
Erector spinae thoracic block with bupivacaine
Arm group label:
Standard of Care + ESB Thoracic
Summary:
The aim of this study is to determine if erector spinae injections with bolus infusions
with local anesthetic decrease postsurgical pain and opioid consumption in patients
undergoing pulmonary resection surgery.
Detailed description:
The research hypothesis for the ESB Thoracic study is that erector spinae blocks with
boluses of bupivacaine infusions will decrease patients' postsurgical pain, and thereby
decrease the amount of narcotic pain medication used. This will be of particular use in
patients who have an anticoagulation need and are not able to receive more invasive nerve
blocks.To achieve appropriate exposure for pulmonary resection surgery, whether open or
video-assisted, patients have surgical incision in the lateral thoracic region, including
disruption to the tributaries of the spinal nerves. Due to this dissection, patients
frequently experience significant pain post-operatively. Erector spinae blocks with
bupivacaine or ropivacaine with bolus infusion therapy have been shown to treat this
spinal nerve pain effectively in rib fractures, thoracoscopic surgeries, and breast
surgeries. However, there have been no definitive studies evaluating the effectiveness of
erector spinae blocks in postoperative pulmonary resection surgery patients.
It is expected that patients with erector spinae blocks (ESB) will have lower pain visual
analogue scores (VAS) and lower total opioid consumption. Learning more about the
effectiveness of ESB can help in providing adjunct therapy and thereby minimize
post-operative opioids, use of which can add further complications in this group of
patients through decreased ventilation and increased atelectasis and hypercarbia. As
well, current neuraxial local anesthetic therapy involving epidurals and paravertebral
blocks require an absence of anticoagulation in the patient; as a fascial plane block,
erector spinae blocks can be safely placed in patients on anticoagulation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- pulmonary resection
- 18
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The George Washington University
Address:
City:
Washington
Zip:
20037
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anita Vincent
Phone:
202-823-4228
Email:
acucchiaro@mfa.gwu.edu
Contact backup:
Last name:
Eduard Shaykhinurov
Phone:
2028234259
Email:
eshaykhinurov@mfa.gwu.edu
Investigator:
Last name:
Anita Vincent, MD
Email:
Principal Investigator
Start date:
July 22, 2022
Completion date:
July 21, 2026
Lead sponsor:
Agency:
George Washington University
Agency class:
Other
Source:
George Washington University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05521789
