NCT06701162

Brief Summary

The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2020

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

November 14, 2024

Last Update Submit

November 20, 2024

Conditions

Keywords

Transverse abdominal plane blocpainanalgesiaultrasoundchildren

Outcome Measures

Primary Outcomes (1)

  • Quality of postoperative analgesia : PPMP score

    The quality of postoperative analgesia described by the pain score : Postoperative Pain Measure for Parents (PPMP) score, minimum value is 0 , maximum value 10 , a value higher than 6 indicates a major pain .

    24 h after surgery

Secondary Outcomes (2)

  • Block execution time

    From the beginning of the practice of the block to the end

  • Complications related to the techniques of nerve block

    Perioperative

Study Arms (2)

TAP group

OTHER

Uktrasound-guided TAP block

Procedure: Ultrasoud-guided TAP block

IIIH block

OTHER

Ultrasound-guided Ilio-inguinal Ilio-Hypogastric Block

Procedure: Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block

Interventions

the ultrasound probe was placed at the mid-axillary line, and the needle was inserted into the space between the internal oblique and transverse muscles, splitting the inter-muscular fascia after injection of local anesthetic.

TAP group

the ultrasound probe was positioned transversely on the abdominal wall at the contact point of the anterosuperior iliac spine. The needle was inserted into the space between the internal oblique and transverse muscles, causing separation of the intermuscular fascia layers upon injection of the anesthetic mixture

IIIH block

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 12 years
  • ASA physical status 1 or 2
  • Scheduled for unilateral inguinal surgery

You may not qualify if:

  • Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
  • Parental refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

Location

MeSH Terms

Conditions

AgnosiaPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The patients were randomly assigned into two groups to receive after a standardized induction of general anesthesia either an ultrasound-guided TAP block or IIIH block with bupivacaine 0.3 ml/kg.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Critical Care

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 22, 2024

Study Start

March 1, 2019

Primary Completion

February 27, 2020

Study Completion

February 27, 2020

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations