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

Post Operative Pain Clinical Trial

— M-TAPA  

Official title:

Medical Doctor of Anesthesiology and Reanimation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06039150
• Other study ID #: GULHANEELAERTEN
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: September 2023
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 52
• Est. completion date: December 21, 2023
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Local Anesthetic
• Pain, Postoperative
• Pediatrics
• Post Operative Pain
• Regional Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara	Kecioren

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ozen V, Acik ME, Ozen N. The modified thoracoabdominal nerve block for post-operative analgesia in paediatric laparoscopic cholecystectomy. J Minim Access Surg. 2023 May 10. doi: 10.4103/jmas.jmas_174_22. Online ahead of print. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of postoperative complications	Patients will be followed up for 24 hours postoperatively for complications including nausea and vomiting and shoulder pain. And it will be recorded.	Postoperative first 24 hours
Primary	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	Comparison of pain between 2 groups in the postoperative period	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.	Postoperative first 24 hours