- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701162
TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY
November 20, 2024 updated by: Mehdi Trifa, Tunis University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery.
This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery.
Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia.
Analgesics were not systematically administered post-induction.
Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed.
At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary.
Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home.
Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tunis, Tunisia, 2001
- Bechir Hamza hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children aged 6 months to 12 years
- ASA physical status 1 or 2
- Scheduled for unilateral inguinal surgery
Exclusion Criteria:
- Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
- Parental refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: TAP group
Uktrasound-guided TAP block
|
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.
|
|
Other: IIIH block
Ultrasound-guided Ilio-inguinal Ilio-Hypogastric Block
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of postoperative analgesia : PPMP score
Time Frame: 24 h after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Block execution time
Time Frame: From the beginning of the practice of the block to the end
|
From the beginning of the practice of the block to the end
|
|
|
Complications related to the techniques of nerve block
Time Frame: Perioperative
|
Complications related to local anesthetics or block technique such as hematoma, spread of local anesthetic to the femoral nerve, intraperitoneal injection ...
|
Perioperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
February 27, 2020
Study Completion (Actual)
February 27, 2020
Study Registration Dates
First Submitted
November 14, 2024
First Submitted That Met QC Criteria
November 20, 2024
First Posted (Estimated)
November 22, 2024
Study Record Updates
Last Update Posted (Estimated)
November 22, 2024
Last Update Submitted That Met QC Criteria
November 20, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 012020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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