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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05121727
Other study ID # E.Kurul-E1-21-1862
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2021
Est. completion date December 1, 2021

Study information

Verified date November 2021
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 and erector spina 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. Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated.There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, 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 ESPB and combined DSAPB-SSAPB pain after VATS.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2021
Est. primary completion date November 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age between 18 and 65 years - American Society of Anesthesiologists physical status I-II-III - Body mass index between 18-30 kg/m2 - Patients undergoing elective video assiste thoracoscopic surgery Exclusion Criteria: - Patient refusing the procedure - History of chronic analgesic or opioid therapy - History of local anesthetic allergy - Infection in the intervention area - Emergency surgery

Study Design


Intervention

Procedure:
Erector Spinae Plane Block
Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position. 20 ml of 0.25% bupivacaine will be used in applications.
Deep and Superficial Serratus Anterior Plane Block
Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position. 20 ml of 0.25% bupivacaine will be used in applications.

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. 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery
Secondary Morphine Consumption Postoperative intravenous morphine infusion therapy will be administered with patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg. 24 hours after surgery
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