Subcostal TAP Block With Single or Multiple Injection

Subcostal Transversus Abdominis Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826652
• Other study ID #: IstanbulMU Subcostal TAP Block
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2023
• Source: Istanbul Medeniyet University
• Contact: Mesure GN Ozden, MD
• Phone: +9005323614400
• Email: nihanozdenn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Subcostal Transversus Abdominis Plane Block

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medeniyet University	I?stanbul
Turkey	Medeniyet University	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tramadol consumption	Postoperative opiod consumption	10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively
Primary	Remifentanil consumption	Intraoperative opiod consumption	up to 2 hours
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	10 minutes postoperatively
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	30 minutes postoperatively
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	1 hours postoperatively
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	3 hours postoperatively
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	6 hours postoperatively
Primary	Verbal Numerical Rating Scala	Verbal Numerical Rating Scala: 0 = no pain; 10 = the most severe pain you can imagine	24 hours postoperatively