Subcostal Transversus Abdominus , Erector Spinae and Paravertebral Blocks Effects on Laparoscopic Cholecystectomy Cases

Not Applicable

Completed

• Conditions: Evaluation; Comparison

• Registration Number: NCT05398406
• Lead Sponsor: Yuzuncu Yıl University

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-08-01
• Study Completion: 2021-01-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
demographic data	6 monthes	age, gender, height, weight, and BMI
Heart rate values	6 monthes	Heart rate values for (-5)-0-30-40 min

Secondary Outcome Measures

Name	Time	Method
postoperative analgesic requirement	6 monthes	the need for postoperative analgesia
postoperative side effects	6 monthes	nausea, vomiting and tremor

Trial Locations

Locations (1)

Van Yuzuncu Yil University; 🇹🇷 VAN, Tuşba, Turkey