Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05398406 |
Other study ID # |
01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
January 1, 2021 |
Study information
Verified date |
May 2022 |
Source |
Yuzuncu Yil University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Sixty patients with ASA (American Society of Anesthesiologist) I-II physical status between
the ages of 20-60 were randomized into three groups: TAP block group (Group T), ESP block
group (Group E) and PVB group (Group P). Bilateral 20cc (total 40cc for each patient) 0.25%
bupivacaine was applied by ultrasound (US) guidance. Intraoperative vital signs (heart rate,
blood pressure, and saturation), Train-of-four (TOF) values, additional dose of opioid and
muscle relaxant needs, complications were recorded. Postoperative side effects (nausea,
vomiting, itching, tremor), the need for additional postoperative analgesia, Visual Analog
Scale (VAS) scores were noted.
Description:
Cases; under the age of 20 - over 60, emerge and bleeding, outside the ASAI-II functional
status, undergo surgery other than laparoscopic cholecystectomy, refused to participate in
the study, allergic to local anesthetic agents, with a body mass index (BMI) >30, have
contraindications for regional anesthesia (sepsis, local infection, coagulopathy, heart
disease, hypovolemia, cases that do not want regional anesthesia), pregnant were not included
in the study.Twenty patients in each group and a total of 60 patients were included the study
by power analysis. According to the randomized, single-blind, closed-envelope method,
patients were randomly divided into three groups.
Group T (Subcostal TAP Block): 40 cc (20cc+20cc) 0.25 % Bupivacaine for bilateral application
Group E (ESP Block): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application Group P
(PVB): 40 cc (20cc+20cc) 0.25% Bupivacaine for bilateral application were prepared.