Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427955
• Other study ID #: E.Kurul-E1-22-2534
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 3, 2023
• Est. primary completion date: December 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Multimodal Analgesia
• Pain, Postoperative
• Thoracic Surgery, Video-Assisted

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	Ankara
Turkey	Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital	Keçiören	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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