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Erector Spinae Block for Post-Surgery Pain in Lung Cancer

Phase 4
Recruiting
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18<age<90
Be older than 18 years old
Must not have
intraoperative complication (inadvertent hemorrhage or conversion to open surgery)
emergent surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 hours postoperatively
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test if shots of painkiller into the spine can help reduce post-surgery pain and the amount of opioids needed for patients having lung surgery.

Who is the study for?
This trial is for adults aged between 18 and 90 who are scheduled to have lung surgery (pulmonary resection). It's not suitable for those needing emergency surgery, procedures like decortication or pleurodesis, people allergic to local anesthetics, or if there are complications during surgery such as heavy bleeding.
What is being tested?
The study is testing whether erector spinae injections with a continuous infusion of local anesthetic can reduce pain and the need for opioid painkillers after lung surgery. The focus is on improving postoperative recovery.
What are the potential side effects?
While specific side effects aren't listed, common ones from similar procedures may include temporary back discomfort at the injection site, potential nerve damage risks, and typical anesthesia-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had complications during surgery, like unexpected bleeding or a change to open surgery.
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I need urgent surgery.
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I have had a procedure to fuse my lung lining.
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I have had surgery to remove parts of both my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hours postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain
Outcome Measure - Pain Score and Pain Medications (24 hours)
Outcome Measure - Pain Score and Pain Medications (6 hours)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + ESB ThoracicExperimental Treatment1 Intervention
Patients randomized to this group will receive an erector spinae block in addition to the standard of care treatment
Group II: Standard of CareActive Control1 Intervention
Patients randomized to this group will receive standard of care treatment and NO erector spinae block

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor
252 Previous Clinical Trials
461,080 Total Patients Enrolled

Media Library

ESB Thoracic Clinical Trial Eligibility Overview. Trial Name: NCT05521789 — Phase 4
Thoracic Tumors Research Study Groups: Standard of Care + ESB Thoracic, Standard of Care
Thoracic Tumors Clinical Trial 2023: ESB Thoracic Highlights & Side Effects. Trial Name: NCT05521789 — Phase 4
ESB Thoracic 2023 Treatment Timeline for Medical Study. Trial Name: NCT05521789 — Phase 4
~16 spots leftby Jul 2025
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