Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Erector Spinae Plane Block; Thoracic Surgery, Video-Assisted; Multimodal Analgesia
• Intervention / Treatment: Procedure: One-level Erector Spinae Plane Block; Procedure: Bi-level Erector Spinae Plane Block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Keçiören, Ankara, Turkey, 06290
      • Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
    • Çankaya, Ankara, Turkey, 06290
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: One-level Erector Spinae Plane Block; One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.
ACTIVE_COMPARATOR: 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.	Procedure: Bi-level Erector Spinae Plane Block; Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	1st hour after surgery
Pain scores	Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	2nd-hour after surgery.
Pain scores	Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	4th-hour after surgery.
Pain scores	Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	12th-hour after surgery.
Pain scores	Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).	24th-hour after surgery.
Pain scores	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).	48th-hour after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Consumption	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.	24 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2022
• Primary Completion (ACTUAL): December 25, 2022
• Study Completion (ACTUAL): February 3, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (ACTUAL): June 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: E.Kurul-E1-22-2534

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No