- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06558331
Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
May 11, 2026 updated by: Cansu KILINC BERKTAS, Başakşehir Çam & Sakura City Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
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
-
-
Istanbul
-
Şişli, Istanbul, Turkey (Türkiye), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
-
-
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
Yes
Study Population
Over 18 years of age
Description
Inclusion Criteria:
- ASA1-3
- Patient undergoing Video Assisted Thoracoscopic Surgery (VATS)
- Over 18 years of age
Exclusion Criteria:
- 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.
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ESPB Group
Patients received ultrasound-guided erector spinae plane block at T4-T5 level
|
Erector spinae plane block: Administration of 30 mL of 0.25% bupivacaine at the T4-T5 level under ultrasound guidance
Other Names:
|
|
Active Comparator: PVB Group
Patients received ultrasound-guided paravertebral block at T5 level
|
Paravertebral block: Administration of 20 mL of 0.375% bupivacaine at the T4-T5 level under ultrasound guidance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score with Numeric Rating Scale (NRS score),
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 1, 2024
Primary Completion (Actual)
February 5, 2025
Study Completion (Actual)
May 6, 2025
Study Registration Dates
First Submitted
August 14, 2024
First Submitted That Met QC Criteria
August 14, 2024
First Posted (Actual)
August 16, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data (IPD) will not be shared.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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