Video-Assisted Thoracic SurgeryNCT06558331
Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
A study testing Bupivacaine 0,25% and Bupivacaine 0,375% in people with Video-Assisted Thoracic Surgery, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Video-Assisted Thoracic Surgery
- What is being tested?
- Bupivacaine 0,25% and Bupivacaine 0,375%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 6 May 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA1-3
- Patient undergoing Video Assisted Thoracoscopic Surgery (VATS)
- Over 18 years of age
Who cannot join
- Sympathectomy, lobectomy and pneumonectomy surgery using Video Assisted Thoracoscopic Surgery (VATS)
- Cases that started with Video Assisted Thoracoscopic Surgery (VATS) but were converted to thoracotomy,
- Patients who were uncooperative,
- Patients who refused to participate in the study,
- Presence of a neuropsychiatric disorder that could bias QoR-15T measurements or emergency surgical intervention,
- Patients under 18 years of age.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam Ve Sakura Şehir Hastanesi
Şişli, Istanbul, 34480
About this study
Official title: Comparison of the Effects of ESP Block and Paravertebral Block on the Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. The quality of recovery after anesthesia (QoR) is an important information of the early health components of patients after surgery. QoR-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. We aimed to investigate the relationship between QoR-15 score and postoperative pain temperature after Video-Assisted Thoracoscopic Surgery (VATS) ESP block and paravertebral spread.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. Despite the improvement in invasiveness against thoracotomy treatment, postoperative pain after VATS was still moderate to severe. In order to accelerate the recovery of patients, a multimodal analgesic should be carefully planned and where it will be beneficial. The quality of recovery after anesthesia (QoR) is an important information of the early health components of patients after surgery. The performance of QoR-15 has been translated into Turkish and validation studies have been conducted on its products. QoR-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. We aimed to investigate the relationship between QoR-15 score and postoperative pain temperature after Video-Assisted Thoracoscopic Surgery (VATS) ESP block and paravertebral spread.
- Conditions
- Video-Assisted Thoracic Surgery
- Being tested
- Bupivacaine 0,25%, Bupivacaine 0,375%
- Keywords
- Video-Assisted Thoracic Surgery, perioperative care, patient-reported outcome measures, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0,25%Drug
Also called ESPB
Erector spinae plane block: Administration of 30 mL of 0.25% bupivacaine at the T4-T5 level under ultrasound guidance
Bupivacaine 0,375%Drug
Also called PVB
Paravertebral block: Administration of 20 mL of 0.375% bupivacaine at the T4-T5 level under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Active comparator | Patients received ultrasound-guided erector spinae plane block at T4-T5 level Receives: Drug: Bupivacaine 0,25% |
| PVB Group | Active comparator | Patients received ultrasound-guided paravertebral block at T5 level Receives: Drug: Bupivacaine 0,375% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ESP block and paravertebral block on QoR-15 Quality of Recovery in VATS surgery
To demonstrate the effect of ESP block and paravertebral block on patient recovery at 24 hours using the Quality of Recovery-15 (QoR-15) scale in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
Measured: 24 hour
Secondary outcomes (1)
Pain score with Numeric Rating Scale (NRS score),
The NRS is a one-dimensional scale using 11 numbers (0 to 10) to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = the worst (unbearable) pain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024
- Primary completion5 Feb 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Video-Assisted Thoracic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our patients who will be included in the study are volunteers who are over 18 years of age and have ASA 1-3 and undergo Video-Assisted Thoracoscopic Surgery (VATS) (excluding lobectomy and pneumonectomy) under elective conditions. Demographic data will be in the form of ASA Score, body mass index (BMI), duration of anesthesia and operation, duration of hospital stay, complications, time until the first additional analgesic requirement, Numerical Rating Scale and Pain score (NRS score), preoperative and postoperative 24th hour QoR-15 survey score.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cansu KILINC BERKTAS, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558331
- Sponsor's protocol ID
- 2024-245
- Status last verified
- May 2026
- First submitted
- 14 Aug 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Publications
Adiyeke O, Berktas CK, Mendes E. Comparison of erector spinae plane block and paravertebral block on quality of recovery-15 after video-assisted thoracoscopic surgery: a prospective randomized study : Regional techniques and quality of recovery after thoracoscopic surgery. BMC Anesthesiol. 2026 May 29;26(1):453. doi: 10.1186/s12871-026-03939-0.
PubMed 42216128
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of ESP Block and Paravertebral Block on the Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT06558331
- Acronym / sponsor ID
- 2024-245
- Conditions
- Video-Assisted Thoracic Surgery
- Keywords
- Video-Assisted Thoracic Surgery, perioperative care, patient-reported outcome measures, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 16 Aug 2024 (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.
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. The quality of recovery after anesthesia (QoR) is an important information of the early health components of patients after surgery. QoR-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. We aimed to investigate the relationship between QoR-15 score and postoperative pain temperature after Video-Assisted Thoracoscopic Surgery (VATS) ESP block and paravertebral spread.
Detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive technique that provides faster recovery after thoracic surgery. Techniques such as thoracic paravertebral block, Erector Spina Plane Expansion (ESP block) are accepted as loco-regional techniques for VATS. Despite the improvement in invasiveness against thoracotomy treatment, postoperative pain after VATS was still moderate to severe. In order to accelerate the recovery of patients, a multimodal analgesic should be carefully planned and where it will be beneficial. The quality of recovery after anesthesia (QoR) is an important information of the early health components of patients after surgery. The performance of QoR-15 has been translated into Turkish and validation studies have been conducted on its products. QoR-15 offers a valid, reliable, sensitive and easy-to-use method for recovery after surgery. We aimed to investigate the relationship between QoR-15 score and postoperative pain temperature after Video-Assisted Thoracoscopic Surgery (VATS) ESP block and paravertebral spread.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Our patients who will be included in the study are volunteers who are over 18 years of age and have ASA 1-3 and undergo Video-Assisted Thoracoscopic Surgery (VATS) (excluding lobectomy and pneumonectomy) under elective conditions. Demographic data will be in the form of ASA Score, body mass index (BMI), duration of anesthesia and operation, duration of hospital stay, complications, time until the first additional analgesic requirement, Numerical Rating Scale and Pain score (NRS score), preoperative and postoperative 24th hour QoR-15 survey score.
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Active comparator | Drug: Bupivacaine 0,25%Patients received ultrasound-guided erector spinae plane block at T4-T5 level |
| PVB Group | Active comparator | Drug: Bupivacaine 0,375%Patients received ultrasound-guided paravertebral block at T5 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA1-3
- Patient undergoing Video Assisted Thoracoscopic Surgery (VATS)
- Over 18 years of age
Key exclusion criteria (6 listed)
- Sympathectomy, lobectomy and pneumonectomy surgery using Video Assisted Thoracoscopic Surgery (VATS)
- Cases that started with Video Assisted Thoracoscopic Surgery (VATS) but were converted to thoracotomy,
- Patients who were uncooperative,
- Patients who refused to participate in the study,
- Presence of a neuropsychiatric disorder that could bias QoR-15T measurements or emergency surgical intervention,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine 0,25%Also: ESPBErector spinae plane block: Administration of 30 mL of 0.25% bupivacaine at the T4-T5 level under ultrasound guidance | Drug | ESPB Group |
| Bupivacaine 0,375%Also: PVBParavertebral block: Administration of 20 mL of 0.375% bupivacaine at the T4-T5 level under ultrasound guidance | Drug | PVB Group |
Primary outcome
Effect of ESP block and paravertebral block on QoR-15 Quality of Recovery in VATS surgery
Time frame: 24 hour
To demonstrate the effect of ESP block and paravertebral block on patient recovery at 24 hours using the Quality of Recovery-15 (QoR-15) scale in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
1 secondary outcome
Pain score with Numeric Rating Scale (NRS score),
Time frame: 1 day
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 13 May 2026.
- Derived from this study: PubMed 42216128Adiyeke O, Berktas CK, Mendes E. Comparison of erector spinae plane block and paravertebral block on quality of recovery-15 after video-assisted thoracoscopic surgery: a prospective randomized study : Regional techniques and quality of recovery after thoracoscopic surgery. BMC Anesthesiol. 2026 May 29;26(1):453. doi: 10.1186/s12871-026-03939-0.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
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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?
A study testing Bupivacaine 0,25% and Bupivacaine 0,375% in people with Video-Assisted Thoracic Surgery, run by Başakşehir Çam & Sakura City Hospital 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 3 inclusion and 6 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 13 May 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?
Effect of ESP block and paravertebral block on QoR-15 Quality of Recovery in VATS surgery (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06558331, which also lists 1 linked publication.
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 13 May 2026.