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

Not Applicable

• Conditions: Laparoscopic Surgery; Regional Anesthesia; Local Anesthetic; Post Operative Pain; Pediatrics
• Interventions: Procedure: Local anesthetic infltration to port sites; Procedure: M-TAPA Block

• Registration Number: NCT06039150
• Lead Sponsor: Gulhane Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Status Verified: 2023-09
• Study First Submitted: 2023-09-03
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2023-10-21
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAİ group	Local anesthetic infltration to port sites	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
M-TAPA group	M-TAPA Block	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Kecioren, Turkey