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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05083845
Other study ID # E.Kurul-E1-21-1964
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date July 9, 2022

Study information

Verified date July 2022
Source Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 9, 2022
Est. primary completion date June 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Turkey Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital Kecioren Ankara

Sponsors (1)

Lead Sponsor Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Morphine Consumption Morphine consumption for 24 hours will be recorded 24 hours after surgery
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