Subcostal TAP Block With Single or Multiple Injection

The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations

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.

Study Overview

• Status: Completed
• Conditions: Subcostal Transversus Abdominis Plane Block
• Intervention / Treatment: Other: Single injection subcostal transversus abdominis plane block; Other: Multiple injection subcostal transversus abdominis plane block; Procedure: Without Block

Detailed Description

A total of 90 patients, aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for laparoscopic cholecystectomy, will be enrolled in this study. Exclusion criteria encompasse a history of allergy to local anesthetics, chronic analgesic use, psychiatric disorders, renal or hepatic dysfunction, coagulopathy, a body mass index (BMI) > 40 kg/m², and pregnancy. Patients in Group S receive a subcostal TAP block with a single injection, patients in Group T receive a subcostal TAP block with multiple injections, and patients in Group C will not receive any form of block.

Standard monitoring protocols will be implemented upon arrival in the operating theatre and heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded during operation. Anesthesia will be induced using propofol (2 mg/kg) and fentanyl (1 μg/kg) and muscle relaxation is achieved with rocuronium (0.5 mg/kg). and maintained using sevoflurane in a 50:50 air/oxygen mixture at a flow rate of 1 L/min. Intraoperative analgesia will be provided through a remifentanil infusion at a rate of 0-0.2 μg/kg/min.

Prior to the initiation of surgery, the subcostal TAP block will be administered in Groups S and T under sterile conditions using ultrasound guidance. 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 left sides of the patients in Group S. The patients in Group T will be given three distinct injections to their left sides: 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.

Laparoscopic cholecystectomy will be performed using four trocar placements on the right side of the abdomen. Postoperative analgesia was managed with a patient-controlled analgesia (PCA) device containing tramadol.

Postoperative remifentanil concumption will be estimated at the end of the operation. Assessments will be conducted at 30th minute, 1st, 3rd, 6st and 24th hours postoperatively, with parameters including pain, nausea, and total PCA consumption. Pain intensity will be measured using the Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain). Postoperative nausea and vomiting (PONV) will be evaluated using a verbal descriptive scale (VDS) (0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV) [10]. Patient satisfaction will beevaluated at discharge using a five-point Likert scale (1 = strongly unsatisfied, 5 = strongly satisfied). Complications, including infection, bleeding, and subcutaneous emphysema will be documented.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul, Turkey, 34730
    • Istanbul Medeniyet University
  • İ̇stanbul, Turkey, 34887
    • Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-65 years old
2. ASA I-III
3. Patients scheduled for laparoscopic cholecystectomy operations

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multiple injection subcostal transversus abdominis plane block; . 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; 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.
Active Comparator: Single injection subcostal transversus abdominis plane block; 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; 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.
Active Comparator: Without Block; The patients in this group will not receive any block	Procedure: Without Block; The patients in this group will not receive block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale	Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine	30. minute
Visual analog scale	Visual ananlog scale: 0 = no pain; 10 = the most severe pain you can imagine	1. hour
Visual analog scale	Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine	3. hour
Visual analog scale	Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine	6. hour
Visual analog scale	Visual analog scale: 0 = no pain; 10 = the most severe pain you can imagine	24. hour
Postoperative nausea and vomiting	Verbal descriptive scale. 0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV	30. minute
Postoperative nausea and vomiting	Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV	1. hour
Postoperative nausea and vomiting	Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV	3. hour
Postoperative nausea and vomiting	Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV	6. hour
Postoperative nausea and vomiting	Verbal descriptive scale:0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV	24. hour
Patient satisfaction	Five-point Likert scale: 1 = strongly unsatisfied, 5 = strongly satisfied	24. hour

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IstanbulMU Subcostal TAP Block

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No