Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Not Applicable

Completed

• Conditions: Pain, Postoperative; Thoracic Surgery, Video-Assisted; Multimodal Analgesia; Erector Spinae Plane Block
• Interventions: Procedure: One-level Erector Spinae Plane Block; Procedure: Bi-level Erector Spinae Plane Block

• Registration Number: NCT05427955
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-22
• Primary Completion: 2022-12-25
• Status Verified: 2023-02
• Study Completion: 2023-02-03
• Last Update Submitted: 2023-02-05
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 and 80 years
• American Society of Anesthesiologists physical status I-II-III
• Body mass index between 18-40 kg/m2
• Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion Criteria

• Patient refusing the procedure
• History of chronic analgesic or opioid therapy
• History of local anesthetic allergy
• Infection in the intervention area
• Emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-level Erector Spinae Plane Block	One-level Erector Spinae Plane Block	After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.
Bi-level Erector Spinae Plane Block	Bi-level Erector Spinae Plane Block	After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T4 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T6 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

Primary Outcome Measures

Name	Time	Method
Pain scores	48th-hour after surgery.	Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Morphine Consumption	24 hours after surgery	Postoperative intravenous morphine infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.

Trial Locations

Locations (2)

Ankara City Hospital; 🇹🇷 Çankaya, Ankara, Turkey

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital; 🇹🇷 Keçiören, Ankara, Turkey