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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05334628
Other study ID # E.Kurul-E1-22-2536
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 11, 2022
Est. completion date October 12, 2022

Study information

Verified date October 2022
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery. General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 12, 2022
Est. primary completion date September 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age between 18 and 80 years - American Society of Anesthesiologists physical status I-II-III - Body mass index between 18-40 kg/m2 - Patients undergoing elective video assisted thoracoscopic surgery Exclusion Criteria: - Advanced cancer - History of chronic analgesic therapy - History of local anesthetic allergy - Infection in the intervention area - Patients with bleeding disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Preoperative Erector spinae plane block
Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position.
Postperative Erector spinae plane block
Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the lateral decubitus position.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean arterial pressure Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia. Perioperative period
Primary Heart rate Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia. Perioperative period
Secondary 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 the 1st, 2nd, 4th, 12th, and 24th hours after surgery. First 24 hours after surgery
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