Quality of Postoperative Recovery (QoR-15T) in Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

NCT06558331 | Completed

• 1 other identifier: 2024-245
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Video-Assisted Thoracic Surgery

Keywords

Video-Assisted Thoracic Surgery; perioperative care; patient-reported outcome measures; pain

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hour

Secondary Outcomes (1)

• Pain score with Numeric Rating Scale (NRS score),

  1 day

Study Arms (2)

ESPB Group

ACTIVE COMPARATOR

Patients received ultrasound-guided erector spinae plane block at T4-T5 level

Drug: Bupivacaine 0,25%

PVB Group

ACTIVE COMPARATOR

Patients received ultrasound-guided paravertebral block at T5 level

Drug: Bupivacaine 0,375%

Interventions

Bupivacaine 0,25% DRUG

Erector spinae plane block: Administration of 30 mL of 0.25% bupivacaine at the T4-T5 level under ultrasound guidance

Also known as: ESPB

ESPB Group

Bupivacaine 0,375% DRUG

Paravertebral block: Administration of 20 mL of 0.375% bupivacaine at the T4-T5 level under ultrasound guidance

Also known as: PVB

PVB Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA1-3
• Patient undergoing Video Assisted Thoracoscopic Surgery (VATS)
• Over 18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Şişli, Istanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients were assigned to Group ESPB or Group PVB using a computer-generated randomization list to ensure unbiased allocation. Allocation concealment was maintained using sealed, opaque envelopes that were opened immediately before block performance by the anesthesiologist performing the procedure.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist MD

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2024
• Primary Completion: February 5, 2025
• Study Completion: May 6, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)