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

• Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05083845
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erector Spinae Plane Block; Local Anesthetic; Thoracotomy; Postoperative Analgesia	Procedure: Same blocks with different local anesthetic volume	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Different Local Anesthetic Volumes for Thoracotomy Patients With Erector Spinae Plane Block
• Actual Study Start Date: Aug 25, 2021
• Actual Primary Completion Date: Jun 9, 2022
• Actual Study Completion Date: Jul 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Pain Scores [48 hours after surgery]

   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.

Secondary Outcome Measures

1. Morphine Consumption [24 hours after surgery]

   Morphine consumption for 24 hours will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital	Kecioren	Ankara	Turkey	06000

Sponsors and Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Musa Zengin, Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05083845
• Other Study ID Numbers: E.Kurul-E1-21-1964
• First Posted: Oct 19, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anesthetics; Anesthetics, Local

Study Results

No Results Posted as of Jul 12, 2022