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

Primary Purpose

Post Operative Pain, Laparoscopic Surgery, Pediatrics

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
M-TAPA Block
Local anesthetic infltration to port sites
Sponsored by
Gulhane Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Gulhane Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

M-TAPA group

LAİ group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2023
Last Updated
September 8, 2023
Sponsor
Gulhane Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06039150
Brief Title
Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies
Acronym
M-TAPA
Official Title
Medical Doctor of Anesthesiology and Reanimation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Laparoscopic Surgery, Pediatrics, Regional Anesthesia, Local Anesthetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M-TAPA group
Arm Type
Experimental
Arm 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.
Arm Title
LAİ group
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
M-TAPA Block
Intervention Description
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
Intervention Name(s)
Local anesthetic infltration to port sites
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total number of rescue analgesic applications
Description
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.
Time Frame
Postoperative first 24 hours
Secondary Outcome Measure Information:
Title
Comparison of pain between 2 groups in the postoperative period
Description
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.
Time Frame
Postoperative first 24 hours
Other Pre-specified Outcome Measures:
Title
Comparison of postoperative complications
Description
Patients will be followed up for 24 hours postoperatively for complications including nausea and vomiting and shoulder pain. And it will be recorded.
Time Frame
Postoperative first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ELA ERTEN
Organizational Affiliation
Anesthesiology and Reanimation department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
State/Province
Kecioren
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21504934
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.
Results Reference
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PubMed Identifier
37282431
Citation
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.
Results Reference
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Modified Thoracoabdominal Nerve Block(M-TAPA) in Pediatric Laparoscopic Appendectomies

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