Clinical trial NCT06039150: Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies
Official title: Medical Doctor of Anesthesiology and Reanimation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Post Operative Pain
Laparoscopic Surgery
Pediatrics
Regional Anesthesia
Local Anesthetic
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-15
Enrollment: 52
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total number of rescue analgesic applications
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Comparison of pain between 2 groups in the postoperative period
timeFrame: Postoperative first 24 hours
Other outcomes:
measure: Comparison of postoperative complications
timeFrame: Postoperative first 24 hours
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
state: Kecioren
Study officials:
affiliation: Anesthesiology and Reanimation department
name: ELA ERTEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.