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

Not Applicable

Completed

• Conditions: Evaluation; Comparison
• Interventions: Other: Erector spinae block group; Other: TAP Block group; Other: Paravertebral block group

• 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

Arm && Interventions

Group	Intervention	Description
ESP Block	Erector spinae block group	In the lateral decubitus position, a 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®,USA) was inserted between the erector spinae muscle and the transverse process structures in an in-plane section guided by US from the T7-8 level. A total of 40 ml of the prepared solutions were injected bilaterally as 20+20 ml.
Subcostal TAP Block	TAP Block group	In the supine position, the US probe was placed on the imaginary line connecting the anterior superior iliac spine (SIAS) and the umbilicus. The ilioinguinal and iliohypogastric nerves in the fascia of the internal obliq and transverse abdominis muscles were visualized by US. A total of 40 ml (20+20 ml) of local anesthetic was infiltrated around the nerve bilaterally with a 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®,USA).
Paravertebral block	Paravertebral block group	In the lateral decubitus position, the cranial to caudal transverse processes and the superior costotransverse ligament and the pleura were visualized from the T7-8 level in the in-plane section under US guidance. A 100 mm 21G peripheral nerve block needle (SonoPlex Stim Cannula, PAJUNK®, USA) was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made bilaterally in the form of 20+20 ml.

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