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

Subcostal Transversus Abdominus Plane Block, Erector Spinae Plane Block and Paravertebral Blocks Effects

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.

Study Overview

• Status: Completed
• Conditions: Comparison; Evaluation
• Intervention / Treatment: Other: TAP Block group; Other: Erector spinae block group; Other: Paravertebral block group

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tuşba
    • VAN, Tuşba, Turkey, 65000
      • Van Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcostal TAP Block; 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).	Other: TAP Block group; TAP Block: the US probe was placed on the imaginary line connecting the anterior superior iliac spine 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 of local anesthetic was infiltrated ESP Blok : a 100 mm 21G peripheral nerve block needle 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. 40 ml of the prepared solutions were injected PVB: 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 was advanced until it passed through the superior costotransverse ligament. A total of 40 ml of injections were made; Other Names: Paravertebral block group; Erector spinae block group
Experimental: ESP Block; 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.	Other: 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.; Other Names: ESP block group
Experimental: Paravertebral block; 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.	Other: 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.; Other Names: PVB group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative analgesic requirement	the need for postoperative analgesia	6 monthes
postoperative side effects	nausea, vomiting and tremor	6 monthes

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Principal Investigator: Arzu E Tekeli, MD, Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: bupivacaine; ultrasonography; plane blocks
• Other Study ID Numbers: 01 (Miami VAHS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No