- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482449
Evaluating the Effectiveness of Postoperative Analgesic Methods in Thoracotomy Cases
March 19, 2026 updated by: Denizhan Acar
Comparison of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Epidural Analgesia Methods in Patients Undergoing Thoracotomy
Effective control of severe post-thoracotomy pain is pivotal for minimizing pulmonary complications and enhancing patient comfort.
This prospective, randomized, three-arm study compared the analgesic efficacy of ultrasound-guided bilateral erector spinae plane block (ESPB) and thoracic epidural analgesia (TEA) with conventional intravenous opioid-based care.
Seventy-two ASA I-II patients aged 18-80 years undergoing elective thoracotomy were block-randomized to receive TEA, ESPB, or no regional intervention (control).
All procedures were performed at the end of surgery before emergence from anesthesia.
Pain intensity was assessed at 1, 2, 4, 6, 12, and 24 h postoperatively using the Visual Analog Scale (VAS).
Additional outcomes included time to first rescue opioid, total tramadol consumption, time to modified Aldrete score (MAS) ≥ 9, patient satisfaction, and length of hospital stay.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Merkez
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Edirne, Merkez, Turkey (Türkiye), 22020
- Trakya University Faculty of Medicine Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients who will undergo thoracotomy surgery
Description
Inclusion Criteria: ASA I-II, Age Range 18-80 years old
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Exclusion Criteria:GKS < 15 LIVER, HEART, LUNG, KIDNEY FAILURE PREGNANCY TRAUMA NEUROLOGICAL DEFICIT
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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TEA ANALGESİA
PATIENTS WHO UNDERWENT TEA AFTER THORACOTOMY CASES
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TEA BLOCK
ATIENTS RECEIVING INTRAVENOUS ANALGESIA AFTER THORACOTOMY CASES
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İV ANALGESİA
PATIENTS RECEIVING INTRAVENOUS ANALGESICS AFTER THORACOTOMY CASES
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of the analgesic efficacy of regional techniques
Time Frame: THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY
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The analgesic efficacy of TEA and ESP blocks after thoracotomy surgeries was evaluated at 1, 2, 4, 6, 12, and 24 hours postoperatively in terms of VAS scores and analgesic drug consumption.
The frequency and amount of tramadol and fentanyl analgesic drug consumption were recorded in the postoperative period.
VAS scores were monitored at the specified times.
The results were compared, and analgesic efficacy was evaluated.
In addition, patient satisfaction (1: excellent, 2: good, 3: moderate, 4: poor), intensive care unit and hospital stay, and postoperative recovery time (using the modified aldarate score) were evaluated.
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THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 8, 2023
Primary Completion (Actual)
May 20, 2025
Study Completion (Actual)
February 12, 2026
Study Registration Dates
First Submitted
March 10, 2026
First Submitted That Met QC Criteria
March 14, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 19, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- TUTF-GOBAEK 2023/190 (Other Identifier: Trakya University Faculty of Medicine Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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