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 left-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: Recruiting
• Conditions: Subcostal Transversus Abdominis Plane Block
• Intervention / Treatment: Other: Single injection subcostal transversus abdominis plane block; Other: Multiple injection subcostal transversus abdominis plane block

Detailed Description

60 patients between 18-65 years of age with ASA I-II who were scheduled for laparoscopic cholecystectomy were included in the study. Patients with local anesthesia allergy, chronic use of analgesics, BMI> 35 kg/m2, psychiatric disease, kidney and/or liver dysfunction, coagulopathy and pregnancy will not be included in the study. The patients who are taken to the operating room will be recorded their first data while standard monitorization is performed.

Propofol 2 mg/kg and fentanyl 1 mg/kg are injected for induction and rocuronium 0.5 mg/kg is injected for muscle relaxation. Patients with adequate muscle relaxation will be intubated with an appropriate endotracheal tube and mechanical ventilation will be initiated. Sevoflurane concentration appropriate for the maintenance of anesthesia will be given in air/O2 mixture at FiO2 with a flow rate of 2 lt / min. For intraoperative analgesia, remifentanil infusion of 0.2mcg / kg / min will be infused. During the operation, arterial pressure will be maintained within the limits of 20% of the initial measurement. The mechanical ventilation parameters will be arranged at the appropriate frequency and tidal volume that make EtCO t 30-40 mmHg. After removal of the gallbladder, Tramadol 1 mg/kg and Metaclopromide 2 mg/kg iv will be administered to all patients. At the end of the operation, a right-sided subcostal transabdominal plan block will be applied to the patients by ultrasound aided. While applying subcostal transabdominal plan block, %2,5 Marcaine 20 ml will be given between transverse and rectus abdominis muscle immediately next to the linea semilunaris in a group of patients. The other group of patients received %2,5 Marcaine 5 ml between the transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volumes lateral to this point near the subcostal margin. Patient-controlled analgesia devices with Tramadol will be prepared for postoperative analgesia. Rest and coughing pains, nausea and total PCA consumption will be recorded10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively. Verbal Numerical Rating Scala (0 = no pain; 10 = the most severe pain you can imagine) for pain and Categorical Scoring Method (0 = none; 1 = less; 2 = too; 3 = too much) for nausea will be used. Complications such as infection, bleeding, and subcutaneous emphysema will be recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mesure GN Ozden, MD; Phone Number: +9005323614400; Email: nihanozdenn@gmail.com

Study Locations

• Turkey
  • İ̇stanbul, Turkey, 34730
    • Recruiting
    • Istanbul Medeniyet University
    • Contact: mesure Gul Nihan Ozden; Phone Number: 05323614400; Email: nihanozdenn@gmail.com
  • İ̇stanbul, Turkey, 34887
    • Recruiting
    • MEDENIYET UNIVERSITY
    • Contact: MESURE GUL NIHAN OZDEN, DOCTOR; Phone Number: +90 5323614400; Email: nihanozdenn@gmail.com

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>35 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: subcostal transversus abdominis plane block; At the end of the operation, a right-sided subcostal transversus abdominis plane block will be applied to the patients by ultrasound aided. While applying the subcostal transabdominal plan block, %2,5 Marcaine 20 ml will be given between the transverse and rectus abdominis muscle immediately next to the linea semilunaris. Patient-controlled analgesia devices with Tramadol will be prepared for postoperative analgesia. Rest and coughing pains, nausea and total PCA consumption will be recorded10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively. Verbal Numerical Rating Scala (0 = no pain; 10 = the most severe pain you can imagine) for pain and Categorical Scoring Method (0 = none; 1 = less; 2 = too; 3 = too much) for nausea will be used. Complications such as infection, bleeding, and subcutaneous emphysema will be recorded.	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: Multiple injection subcostal transversus abdominis plane block; At the end of the operation, a right-sided subcostal transversus abdominis plane block will be applied to the patients by ultrasound aided. patients received %2,5 Marcaine 5 ml between the transverse and rectus abdominis muscle, 5 ml on the transverse muscle near the semilunaris and two more 5 ml volumes lateral to this point near the subcostal margin. Patient-controlled analgesia devices with Tramadol will be prepared for postoperative analgesia. Rest and coughing pains, nausea and total PCA consumption will be recorded10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively. Verbal Numerical Rating Scala (0 = no pain; 10 = the most severe pain you can imagine) for pain and Categorical Scoring Method (0 = none; 1 = less; 2 = too; 3 = too much) for nausea will be used. Complications such as infection, bleeding, and subcutaneous emphysema will be recorded.	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.

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
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	10 minutes postoperatively
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	30 minutes postoperatively
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	1 hours postoperatively
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	3 hours postoperatively
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	6 hours postoperatively
Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): 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): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

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