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

NCT05398406 | Completed DMC

• 1 other identifier: 01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Comparison; Evaluation

Keywords

plane blocks; ultrasonography; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity measured by 10-cm Visual Analogue Scale (VAS)

  Pain intensity assessed using a 10-cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

  6 hours postoperatively

Secondary Outcomes (5)

• Postoperative rescue analgesic requirement

  Within the first 6 hours postoperatively

• Intraoperative opioid consumption

  During surgery

• Intraoperative neuromuscular blocker requirement

  During surgery

• Incidence of postoperative adverse events

  Within the first 6 hours postoperatively

• Time to first mobilization

  Within the first 6 hours postoperatively

Study Arms (3)

Subcostal TAP Block

EXPERIMENTAL

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

ESP Block

EXPERIMENTAL

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

Paravertebral block

EXPERIMENTAL

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

Interventions

TAP Block group 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

Also known as: Paravertebral block group, Erector spinae block group

Subcostal TAP Block

Paravertebral block group 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.

Also known as: PVB group

Paravertebral block

Erector spinae block group 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.

Also known as: ESP block group

ESP Block

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years,
• ASA I-II ,
• scheduled for elective laparoscopic cholecystectomy
• under general anesthesia,
• agreed to participate in the study,

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University

Van, Tuşba, 65000, Turkey (Türkiye)

Location

Study Officials

• Arzu E Tekeli, MD

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This was a single-blind study. Participants and the investigator assessing postoperative outcomes were blinded to group allocation. The anesthesiologist performing the regional blocks was not involved in postoperative data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomized, single-blind, closed-envelope method

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 1, 2022
• Study Start: January 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2021
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

TU (1)