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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05255536
Other study ID # E.Kurul-E1-22-2371
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date May 15, 2024

Study information

Verified date February 2024
Source Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Contact Musa Zengin, MD
Phone 903125677233
Email musazengin@gmail.com
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. In addition, SAPB 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 SAPB block to be performed with USG in patients who underwent VATS.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 15, 2024
Est. primary completion date April 15, 2024
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:
Serratus Anterior Plan Block with 20 ml
Superficial serratus anterior plane block with 20 ml will be applied to the patients under real-time ultrasound guidance.
Serratus Anterior Plan Block with 30 ml
Superficial serratus anterior plane block with 30 ml 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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