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Erector Spinae Block for Thoracic Surgery

Primary Purpose

Pulmonary Neoplasm, Pulmonary Cancer, Thoracic Diseases

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ESB Thoracic
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Neoplasm

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pulmonary resection
  • 18<age<90

Exclusion Criteria:

  • pleurodesis
  • decortication
  • emergent surgery
  • local anesthetic allergy
  • intraoperative complication (inadvertent hemorrhage or conversion to open surgery)
  • bilateral pulmonary resection

Sites / Locations

  • The George Washington UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard of Care + ESB Thoracic

Standard of Care

Arm Description

Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment

Patients randomized to this group will receive standard of care treatment and NO erector spinae block

Outcomes

Primary Outcome Measures

Outcome Measure - Pain Score and Pain Medications (6 hours)
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 6 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Outcome Measure - Pain Score and Pain Medications (12 hours)
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 12 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Outcome Measure - Pain Score and Pain Medications (24 hours)
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 24 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2022
Last Updated
September 5, 2023
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT05521789
Brief Title
Erector Spinae Block for Thoracic Surgery
Official Title
Erector Spinae Blocks for Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
July 21, 2024 (Anticipated)
Study Completion Date
July 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Neoplasm, Pulmonary Cancer, Thoracic Diseases, Thoracic Cancer, Thoracic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care + ESB Thoracic
Arm Type
Experimental
Arm Description
Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients randomized to this group will receive standard of care treatment and NO erector spinae block
Intervention Type
Drug
Intervention Name(s)
ESB Thoracic
Intervention Description
Erector spinae thoracic block with bupivacaine
Primary Outcome Measure Information:
Title
Outcome Measure - Pain Score and Pain Medications (6 hours)
Description
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 6 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Time Frame
At 6 hours postoperatively
Title
Outcome Measure - Pain Score and Pain Medications (12 hours)
Description
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 12 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Time Frame
At 12 hours postoperatively
Title
Outcome Measure - Pain Score and Pain Medications (24 hours)
Description
Study team members will record the patients' visual analogue pain score pain score on the scale of 0-10 (pain score 0-10 numerical rating) at 24 hours, as well as pain medications given. In addition, all patients will receive a Pain Diary with which to record the pain scores and medications received/taken. If a patient is discharged prior to the 24 hours, the patient will continue to fill out the Pain Diary at home up to the 24 hour mark. A phone call by a member of the study team within 72 hours of leaving the hospital will be initiated to review the Pain Diary for data collection purposes.
Time Frame
At 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pulmonary resection 18<age<90 Exclusion Criteria: pleurodesis decortication emergent surgery local anesthetic allergy intraoperative complication (inadvertent hemorrhage or conversion to open surgery) bilateral pulmonary resection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Shaykhinurov
Phone
2028234259
Email
eshaykhinurov@mfa.gwu.edu
Facility Information:
Facility Name
The George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Vincent
Phone
202-823-4228
Email
acucchiaro@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Eduard Shaykhinurov
Phone
2028234259
Email
eshaykhinurov@mfa.gwu.edu
First Name & Middle Initial & Last Name & Degree
Anita Vincent, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Erector Spinae Block for Thoracic Surgery

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