The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block

NCT ID: NCT05083845

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2022-07-09

Brief Summary

It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.

Conditions

Erector Spinae Plane Block; Local Anesthetic; Thoracotomy; Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area.

Group Type: ACTIVE_COMPARATOR

Same blocks with different local anesthetic volume

Intervention Type: PROCEDURE

Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.

Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine was injected into the area.

Group Type: ACTIVE_COMPARATOR

Same blocks with different local anesthetic volume

Intervention Type: PROCEDURE

Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.

Interventions

Same blocks with different local anesthetic volume

Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years old
• ASA physical status I-II-III
• BMI 18 to 30 kg/m2
• Elective thoracotomy surgery

Exclusion Criteria

• Patient refusing the procedure
• Emergency surgery
• History of chronic opioid or analgesic used

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Musa Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Zengin M, Sazak H, Baldemir R, Ulger G, Arican D, Kaybal O, Alagoz A. Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. BMC Anesthesiol. 2023 Feb 6;23(1):42. doi: 10.1186/s12871-023-02004-4.

Reference Type: DERIVED

PMID: 36747119 (View on PubMed)

Other Identifiers

E.Kurul-E1-21-1964

Identifier Type: -

Identifier Source: org_study_id