Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001389594p
Ethics application status
Not yet submitted
Date submitted
25/10/2024
Date registered
22/11/2024
Date last updated
22/11/2024
Date data sharing statement initially provided
22/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain response to laparoscopic inguinal hernia repair in newborns and infants using different anesthetic modalities.
Scientific title
Newborn/infant parasympathetic evaluation (NIPE) to evaluate intraoperative pain response in neonates (<28 days) and infants (<2 years) undergoing laparoscopic inguinal hernia repair under general anaesthesia + caudal block vs general anaesthesia + local infiltration
Secondary ID [1] 313045 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NIPE-LIH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernias 335268 0
Condition category
Condition code
Surgery 331839 331839 0 0
Other surgery
Anaesthesiology 331840 331840 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to receive Local Infiltration will receive 1-1.2ml/kg Ropivacaine 0.2% (infants <10kg) or 0.3ml/kg 0.75% Ropivacaine diluted to volume of 10mls with 0.9% NaCl. before the skin incisions.

A 10 mL syringe will be used to inject the local anesthetic using a standardised technique:
The needle is inserted directly into the subdermal layer at the area of the incision. The syringe is aspirated to exclude intravascular placement. 2 mL of the anesthetic are injected at the umbilicus while withdrawing the needle. A similar technique is used to inject a 1 mL of the anesthetic in the left and right flanks.

Two minutes are waited for the anesthetic to take effect before the skin incisions.
Intervention code [1] 329596 0
Treatment: Surgery
Comparator / control treatment
Patients randomised to the Caudal Block group will receive a single shot caudal anaesthetic prior to the start of surgery with 1.0-1.2ml/kg 0.2% Ropivacaine.

With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus is identified using the conventional landmark technique; the sacrococcygeal ligament is palpated between the two sacral cornua, and the needle is inserted in the skin at a 45° angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle which is then advanced to the correct final position. Before the local anaesthetic is applied, aspiration or passive drainage is performed to rule out an inadvertent intravascular or spinal needle location.
Control group
Active

Outcomes
Primary outcome [1] 339493 0
Intra-operative pain
Timepoint [1] 339493 0
Absolute NIPE indices will also be recorded at the time of endotracheal intubation, venous cannulation, peripheral nerve block administration, skin incision, skin closure and extubation
Primary outcome [2] 339495 0
Analgesia Requirement
Timepoint [2] 339495 0
Every 10 minutes while in PACU
Primary outcome [3] 339494 0
Post-operative pain
Timepoint [3] 339494 0
Every 10 minutes while in Post-Anaesthesia Care Unit (PACU)
Secondary outcome [1] 440191 0
Time to 'ready for discharge'
Timepoint [1] 440191 0
At time of 'ready for discharge' from PACU
Secondary outcome [2] 440188 0
Episodes of post-operative vomiting
Timepoint [2] 440188 0
Every 10 minutes while in PACU
Secondary outcome [3] 440189 0
Requirement for anti-emetic drugs
Timepoint [3] 440189 0
Every 10 minutes while in PACU

Eligibility
Key inclusion criteria
All children 2 years of age and under, with no significant associated co-morbidities, who are undergoing elective laparoscopic inguinal hernia repair will be included.
Minimum age
No limit
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have cardiac, respiratory or neurological conditions will be excluded, as well as premature babies below 46 weeks post-conceptional age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to either CB or LI using minimisation for corrected gestational age, weight and sex
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using GraphPad Prism version 10.1.0 (Graph-Pad Software, San Diego, California USA). Normality will be tested with the Shapiro-Wilk normality test. Group comparisons performed using Mann-Whitney U test, Unpaired t-test and Fisher’s Exact test when appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
24/10/2025
Actual
Date of last data collection
Anticipated
24/10/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27152 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 43232 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 317486 0
Hospital
Name [1] 317486 0
Monash Children's Hospital
Country [1] 317486 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 319812 0
None
Name [1] 319812 0
Address [1] 319812 0
Country [1] 319812 0
Other collaborator category [1] 283268 0
University
Name [1] 283268 0
Monash University
Address [1] 283268 0
Country [1] 283268 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316199 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316199 0
Ethics committee country [1] 316199 0
Australia
Date submitted for ethics approval [1] 316199 0
25/11/2024
Approval date [1] 316199 0
Ethics approval number [1] 316199 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137114 0
Dr Maurizio Pacilli
Address 137114 0
Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
Country 137114 0
Australia
Phone 137114 0
+61 385723838
Fax 137114 0
Email 137114 0
[email protected]
Contact person for public queries
Name 137115 0
Maurizio Pacilli
Address 137115 0
Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
Country 137115 0
Australia
Phone 137115 0
+61 385723838
Fax 137115 0
Email 137115 0
[email protected]
Contact person for scientific queries
Name 137116 0
Maurizio Pacilli
Address 137116 0
Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
Country 137116 0
Australia
Phone 137116 0
+61 385723838
Fax 137116 0
Email 137116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.