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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05255562
Other study ID # E.Kurul-E1-22-2372
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date May 16, 2023

Study information

Verified date May 2023
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

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, serratus anterior plane block (SAPB), and erector spinae 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 and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, a local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB and combined SAPB (CSAPB) after VATS.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 16, 2023
Est. primary completion date May 1, 2023
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 video-assisted thoracoscopic surgery Exclusion Criteria: - Patient refusing the procedure - Emergency surgery - Chronic opioid or analgesic use

Study Design


Intervention

Procedure:
Combined Serratus Anterior Plane Block
Combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.
Drug:
Thoracic Paravertebral Block
Thoracic paravertebral block 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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