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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06073197
Other study ID # 2020-11/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2020
Est. completion date February 25, 2021

Study information

Verified date October 2023
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery. Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery. Interventions: Preoperative SAPB or ESPB implementation.


Description:

Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS Exclusion Criteria: - Patients who did not give consent - Local anaesthetic allergy - Known or suspected coagulopathy - Infection at the injection site - History of thoracic surgery - Severe cardiovascular disease - Hepatic or renal insufficiency (glomerular filtration rate <15 ml/min/1.73 m2) - Severe neurological or psychiatric disorders - Chronic opioid use

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
erector spinae plane block
Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
combined deep and superficial serratus anterior plane block
Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.

Locations

Country Name City State
Turkey Bursa Uludag University Bursa

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative analgesic effects The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10). first 48 hours
Primary intraoperative analgesic effects The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups. intraoperative phase
Secondary side effects The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present. first 48 hours
Secondary complications The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block. first 48 hours
Secondary mobilization The secondary aim was to compare the mobilization time first 48 hours
Secondary stay of hospital length of stay in the recovery unit and hospital first 4 days
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