NCT05521789

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
15mo left

Started Jul 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jul 2022Jul 2027

Study Start

First participant enrolled

July 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4.4 years

First QC Date

August 23, 2022

Last Update Submit

February 23, 2026

Conditions

Thoracic NeoplasmsPulmonary NeoplasmPulmonary CancerThoracic DiseasesThoracic Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Standard of Care + ESB Thoracic

EXPERIMENTAL

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

Drug: ESB Thoracic

Standard of Care

NO INTERVENTION

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

Interventions

ESB ThoracicDRUG

Erector spinae thoracic block with bupivacaine

Standard of Care + ESB Thoracic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pulmonary resection
  • \<age\<90

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsThoracic DiseasesThoracic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Eduard Shaykhinurov

CONTACT

2028234259eshaykhinurov@mfa.gwu.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 30, 2022

Study Start

July 22, 2022

Primary Completion (Estimated)

December 21, 2026

Study Completion (Estimated)

July 21, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)