Thoracotomy AnalgesiaNCT07482449
Evaluating the Effectiveness of Postoperative Analgesic Methods in Thoracotomy Cases
An observational study of Thoracotomy Analgesia, run by Denizhan Acar at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracotomy Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2023to 12 Feb 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who will undergo thoracotomy surgery
Who may be able to join
- -
- Exclusion Criteria:GKS < 15 LIVER, HEART, LUNG, KIDNEY FAILURE PREGNANCY TRAUMA NEUROLOGICAL DEFICIT
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Faculty of Medicine Hospital
Edirne, Merkez, 22020
About this study
Official title: 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.
- Conditions
- Thoracotomy Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEA ANALGESİA | PATIENTS WHO UNDERWENT TEA AFTER THORACOTOMY CASES | |
| TEA BLOCK | ATIENTS RECEIVING INTRAVENOUS ANALGESIA AFTER THORACOTOMY CASES | |
| İV ANALGESİA | PATIENTS RECEIVING INTRAVENOUS ANALGESICS AFTER THORACOTOMY CASES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the analgesic efficacy of regional techniques
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.
Measured: THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start8 May 2023
- Primary completion20 May 2025
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracotomy AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Denizhan Acar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Denizhan Acar, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482449
- Sponsor's protocol ID
- TUTF-GOBAEK 2023/190
- Other IDs
- TUTF-GOBAEK 2023/190
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Epidural Analgesia Methods in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT07482449
- Acronym / sponsor ID
- TUTF-GOBAEK 2023/190
- Conditions
- Thoracotomy Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Denizhan AcarUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TEA ANALGESİA | – | –PATIENTS WHO UNDERWENT TEA AFTER THORACOTOMY CASES |
| TEA BLOCK | – | –ATIENTS RECEIVING INTRAVENOUS ANALGESIA AFTER THORACOTOMY CASES |
| İV ANALGESİA | – | –PATIENTS RECEIVING INTRAVENOUS ANALGESICS AFTER THORACOTOMY CASES |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who will undergo thoracotomy surgery
Key inclusion criteria (2 listed)
- -
- Exclusion Criteria:GKS < 15 LIVER, HEART, LUNG, KIDNEY FAILURE PREGNANCY TRAUMA NEUROLOGICAL DEFICIT
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the analgesic efficacy of regional techniques
Time frame: THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracotomy Analgesia, run by Denizhan Acar at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the analgesic efficacy of regional techniques (time frame: THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.