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

NCT06039150 | Unknown

• 1 other identifier: GULHANEELAERTEN
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Laparoscopic Surgery; Pediatrics; Regional Anesthesia; Local Anesthetic

Outcome Measures

Primary Outcomes (1)

• Total number of rescue analgesic applications

  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.

  Postoperative first 24 hours

Secondary Outcomes (1)

• Comparison of pain between 2 groups in the postoperative period

  Postoperative first 24 hours

Other Outcomes (1)

• Comparison of postoperative complications

  Postoperative first 24 hours

Study Arms (2)

M-TAPA group

EXPERIMENTAL

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

LAİ group

ACTIVE COMPARATOR

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

Interventions

M-TAPA Block PROCEDURE

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.

M-TAPA group

Local anesthetic infltration to port sites PROCEDURE

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.

LAİ group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Kecioren, 06010, Turkey (Türkiye)

Location

Related Publications (2)

• Sandeman DJ, Bennett M, Dilley AV, Perczuk A, Lim S, Kelly KJ. Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. Br J Anaesth. 2011 Jun;106(6):882-6. doi: 10.1093/bja/aer069. Epub 2011 Apr 18.

  PMID: 21504934 BACKGROUND

• Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2024 Oct 1;20(4):452-455. doi: 10.4103/jmas.jmas_174_22. Epub 2023 May 10.

  PMID: 37282431 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• ELA ERTEN

  Anesthesiology and Reanimation department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 3, 2023
• First Posted: September 15, 2023
• Study Start: August 21, 2023
• Primary Completion: October 21, 2023
• Study Completion: December 21, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)