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

Sponsor

Yuzuncu Yıl University (Other)

Overall Status

Completed

CT.gov ID

NCT05398406

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Comparison Evaluation	Other: TAP Block group Other: Paravertebral block group Other: Erector spinae block group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

randomized, single-blind, closed-envelope methodrandomized, single-blind, closed-envelope method

Masking:

Single (Participant)

Masking Description:

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

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

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

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

Other Names:

PVB group

Outcome Measures

Primary Outcome Measures

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

postoperative analgesic requirement [6 monthes]
the need for postoperative analgesia
postoperative side effects [6 monthes]
nausea, vomiting and tremor

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yuzuncu Yil University	VAN	Tuşba	Turkey	65000

Sponsors and Collaborators

Yuzuncu Yıl University

Investigators

Principal Investigator: Arzu E Tekeli, MD, Yuzuncu Yıl University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arzu Esen Tekeli, Associate Professor, Yuzuncu Yıl University

ClinicalTrials.gov Identifier:

NCT05398406

Other Study ID Numbers:

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arzu Esen Tekeli, Associate Professor, Yuzuncu Yıl University

plane blocks

ultrasonography

bupivacaine

Study Results

No Results Posted as of Jun 1, 2022