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

NCT ID: NCT05398406

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-01

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.

Conditions

Comparison; Evaluation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

TAP Block group

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Erector spinae block group

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Paravertebral block group

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Paravertebral block group; Erector spinae block group; PVB group; ESP block group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yuzuncu Yıl University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Esen Tekeli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu E Tekeli, MD

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Locations

Van Yuzuncu Yil University

Van, Tuşba, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id