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

G

Gulhane Training and Research Hospital

Status

Invitation-only

Conditions

Laparoscopic Surgery
Pediatrics
Local Anesthetic
Regional Anesthesia
Post Operative Pain

Treatments

Procedure: M-TAPA Block
Procedure: Local anesthetic infltration to port sites

Study type

Interventional

Funder types

Other

Identifiers

NCT06039150
GULHANEELAERTEN

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

7 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups

M-TAPA group
Experimental group
Description:
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.
Treatment:
Procedure: M-TAPA Block
LAİ group
Active Comparator group
Description:
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
Treatment:
Procedure: Local anesthetic infltration to port sites

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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