Erector Spinae Block for Thoracic Surgery

Erector Spinae Blocks for Thoracic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Neoplasms; Thoracic Cancer; Thoracic Diseases; Pulmonary Cancer; Pulmonary Neoplasm
• Intervention / Treatment: Drug: ESB Thoracic

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eduard Shaykhinurov; Phone Number: 2028234259; Email: eshaykhinurov@mfa.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Recruiting
      • The George Washington University
      • Principal Investigator: Anita Vincent, MD
      • Contact: Anita Vincent; Phone Number: 202-823-4228; Email: acucchiaro@mfa.gwu.edu
      • Contact: Eduard Shaykhinurov; Phone Number: 2028234259; Email: eshaykhinurov@mfa.gwu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care + ESB Thoracic; Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment	Drug: ESB Thoracic; Erector spinae thoracic block with bupivacaine
No Intervention: Standard of Care; Patients randomized to this group will receive standard of care treatment and NO erector spinae block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 hours postoperatively
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.	At 12 hours postoperatively
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.	At 24 hours postoperatively

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): July 21, 2027

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Lung Neoplasms; Thoracic Neoplasms; Thoracic Diseases
• Other Study ID Numbers: NCR213913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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