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

NCT ID: NCT06039150

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2023-12-21

Brief Summary

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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

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Conditions

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Post Operative Pain Laparoscopic Surgery Pediatrics Regional Anesthesia Local Anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M-TAPA group

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.

Group Type EXPERIMENTAL

M-TAPA Block

Intervention Type 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.

LAİ group

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

Group Type ACTIVE_COMPARATOR

Local anesthetic infltration to port sites

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gulhane Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ELA ERTEN

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ELA ERTEN

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology and Reanimation department

Locations

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Gulhane Training and Research Hospital

Ankara, Kecioren, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21504934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37282431 (View on PubMed)

Other Identifiers

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GULHANEELAERTEN

Identifier Type: -

Identifier Source: org_study_id

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