Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies

Sponsor

Gulhane Training and Research Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06039150

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the effect of M-TAPA block and port-site local anesthetic infiltration on postoperative pain in pediatric laparoscopic appendectomies. The main questions it aims to answer are:

Is M-TAPA block more effective in reducing pain?
How M-TAPA block affects the use of rescue analgesics in the postoperative period? Participants will have the same anaesthetic agents during surgery, before extubation they will have same analgesic agent for postoperative pain. Participants in the M-TAPA group will undergo USG-guided M-TAPA block bilaterally with % 0.025 Bupivacaine max dose of 2 mg/kg by the same experienced anesthesiologist before extubation. Participants in the LAI group will be administered 0.025% Bupivacaine at a maximum dose of 2mg/kg divided equally and administered by the surgeon at 3 port entry sites before the patient is extubated.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Laparoscopic Surgery Pediatrics Regional Anesthesia Local Anesthetic	Procedure: M-TAPA Block Procedure: Local anesthetic infltration to port sites	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Medical Doctor of Anesthesiology and Reanimation

Actual Study Start Date :

Aug 21, 2023

Anticipated Primary Completion Date :

Oct 21, 2023

Anticipated Study Completion Date :

Dec 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: M-TAPA group The group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation.	Procedure: M-TAPA Block M-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue.
Active Comparator: LAİ group The group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation	Procedure: Local anesthetic infltration to port sites Local anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery.

Arm

Intervention/Treatment

Experimental: M-TAPA group

The group to be administered 0.025% Bupivacaine by the anesthesiologist bilaterally in M-TAPA block with a maximum dose of 2 mg/kg before extubation.

Procedure: M-TAPA Block

M-TAPA Block; The block will be done by the same experienced anesthesiologist by using ultrasound(USG) after the surgical intervention is completed.The external oblique, internal oblique, and transversus abdominis muscles were shown on the costochondral angle in the sagittal plane at the 10th costal margin by using a high-frequency linear probe. Bilaterally in the midclavicular line at the level of the 10th rib (arcus costarum),0,5 ml/kg 0.25% Bupivacaine (maximum dose 2mg/kg) was administered to between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue.

Active Comparator: LAİ group

The group to be divided and administered 0.025% Bupivacaine with a maximum dose of 2 mg/kg by the surgeon to 3 port entry sites before extubation

Procedure: Local anesthetic infltration to port sites

Local anesthetic infiltration to port sites; The surgeon infiltrated 0.5 ml/kg of 0.25% Bupivacaine (maximum dose of 2mg/kg) in the skin, subcutaneous tissue, and muscle fascia at each of the three laparoscopic port areas at the end of the surgery.

Outcome Measures

Primary Outcome Measures

Total number of rescue analgesic applications [Postoperative first 24 hours]
During the first 24 hours postoperatively, patients' pain will be monitored by Visual Analogue Scale (VAS) scoring. Paracetamol will be given intravenously at a dose of 10mg/kg if the VAS is greater than 4 in pain assessment in the postoperative period. We will record the number of times the patient received rescue analgesics over a 24-hour period.

Secondary Outcome Measures

Comparison of pain between 2 groups in the postoperative period [Postoperative first 24 hours]
The Visual Analogue Scale (VAS) scores were recorded postoperatively at 0 (PACU), 1, 4, 6, 12, and 24 h. Visual Analogue Scale (VAS) Scale vertical or horizontal from a 10 cm long line drawn as is formed. At the two ends of this line are the two end descriptor word (0 = "no pain at all", 10 = worst/unbearable pain").The patient is asked to place a mark in the appropriate place for the intensity of the pain.

Other Outcome Measures

Comparison of postoperative complications [Postoperative first 24 hours]
Patients will be followed up for 24 hours postoperatively for complications including nausea and vomiting and shoulder pain. And it will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with American society of Anesthesiologists (ASA) physical status I-II,
Patients which will undergo Laparoscopic appendectomy due to the diagnosis of acute appendicitis,
Patients whose parents or legal heirs have consented to participate in the study

Exclusion Criteria:

Patients with Society of Anesthesiologists (ASA) III-IV status,
Patients whose parents or legal heirs' disapproval,
Patients inability to cooperate,
Patients who have allergy to any of the medications used in the study,
Patients with perforated appendix
When the Laparoscopic surgery returns to open shape

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gulhane Training and Research Hospital	Ankara	Kecioren	Turkey	06010

Sponsors and Collaborators

Gulhane Training and Research Hospital

Investigators

Principal Investigator: ELA ERTEN, Anesthesiology and Reanimation department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

ELA ERTEN, Medical Doctor, Gulhane Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT06039150

Other Study ID Numbers:

GULHANEELAERTEN

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Anesthetics

Anesthetics, Local

Study Results

No Results Posted as of Sep 15, 2023