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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05427955
Other study ID # E.Kurul-E1-22-2534
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2022
Est. completion date February 3, 2023

Study information

Verified date February 2023
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) 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 is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 3, 2023
Est. primary completion date December 25, 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: - 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:
One-level Erector Spinae Plane Block
One-level 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. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.
Bi-level Erector Spinae Plane Block
Bi-level 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. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.

Locations

Country Name City State
Turkey Ankara City Hospital Çankaya Ankara
Turkey Ankara Atatürk Chest Diseases and Thoracic 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 Pain scores Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 1st hour after surgery
Primary Pain scores Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 2nd-hour after surgery.
Primary Pain scores Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 4th-hour after surgery.
Primary Pain scores Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 12th-hour after surgery.
Primary Pain scores Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 24th-hour after surgery.
Primary Pain scores Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). 48th-hour after surgery.
Secondary Morphine Consumption Postoperative intravenous morphine infusion therapy will be administered with the 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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