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

NCT05083845 | Completed

• 1 other identifier: E.Kurul-E1-21-1964
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.

  48 hours after surgery

Secondary Outcomes (1)

• Morphine Consumption

  24 hours after surgery

Study Arms (2)

Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine

ACTIVE COMPARATOR

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.

Procedure: Same blocks with different local anesthetic volume

Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine

ACTIVE COMPARATOR

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.

Procedure: Same blocks with different local anesthetic volume

Interventions

Same blocks with different local anesthetic volume 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 20 ml %0.25 Bupivacaine; Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 36747119 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 19, 2021
• Study Start: August 25, 2021
• Primary Completion: June 9, 2022
• Study Completion: July 9, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)