Subcostal TAP Block With Single or Multiple Injection

NCT05826652 | Completed

• 1 other identifier: IstanbulMU Subcostal TAP Block
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Considering that applying technique is important in this block, the results of this study can guide practitioners in this field.

Conditions

Subcostal Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (2)

• Tramadol consumption

  Postoperative opiod consumption

  10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively

• Remifentanil consumption

  Intraoperative opiod consumption

  up to 2 hours

Secondary Outcomes (11)

• Visual analog scale

  30. minute

• Visual analog scale

  1. hour

• Visual analog scale

  3. hour

• Visual analog scale

  6. hour

• Visual analog scale

  24. hour

Study Arms (3)

Multiple injection subcostal transversus abdominis plane block

ACTIVE COMPARATOR

. The patients in multiple injection will be given three distinct injections: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.

Other: Multiple injection subcostal transversus abdominis plane block

Single injection subcostal transversus abdominis plane block

ACTIVE COMPARATOR

A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the patients in Group S.

Other: Single injection subcostal transversus abdominis plane block

Without Block

ACTIVE COMPARATOR

The patients in this group will not receive any block

Procedure: Without Block

Interventions

Single injection subcostal transversus abdominis plane block OTHER

Single injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 20 ml between tranvers and rectus abdominis muscle immediately next to the linea semilunaris.

Single injection subcostal transversus abdominis plane block

Multiple injection subcostal transversus abdominis plane block OTHER

Multiple injection subcostal transversus abdominis plane block will be applied with %2,5 Marcaine 5 ml between transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volume lateral to this point near the subcostal margin.

Multiple injection subcostal transversus abdominis plane block

Without Block PROCEDURE

The patients in this group will not receive block

Without Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA I-III
• Patients scheduled for laparoscopic cholecystectomy operations

You may not qualify if:

• Those who have previously had neurological and psychiatric disease symptoms and use drugs (TIA, syncope, dementia, depression, bipolar disorder, etc.)
• Patients with known allergy to local anesthetics
• Chronic opioid or corticosteroid users
• Those with coagulopathy
• Those with local or systemic infections
• BMI\>40 kg/m2

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (2)

Istanbul Medeniyet University

Istanbul, 34730, Turkey (Türkiye)

Location

Medeniyet University

Istanbul, 34887, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 24, 2023
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2023
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)