Clinical trial NCT05398406: Subcostal Transversus Abdominus , Erector Spinae and Paravertebral Blocks Effects on Laparoscopic Cholecystectomy Cases
Official title: Subcostal Transversus Abdominus Plane Block, Erector Spinae Plane Block and Paravertebral Blocks Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison
Evaluation
Keywords: plane blocks
ultrasonography
bupivacaine
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized, single-blind, closed-envelope method
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 20-60 years,
* ASA I-II ,
* scheduled for elective laparoscopic cholecystectomy
* under general anesthesia,
* agreed to participate in the study,

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: demographic data
timeFrame: 6 monthes
measure: Heart rate values
timeFrame: 6 monthes
Secondary outcomes:
measure: postoperative analgesic requirement
timeFrame: 6 monthes
measure: postoperative side effects
timeFrame: 6 monthes
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yuzuncu Yil University
state: Tuşba
Study officials:
affiliation: Yuzuncu Yıl University
name: Arzu E Tekeli, MD
role: PRINCIPAL_INVESTIGATOR
References: