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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.
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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
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Secondary ID [1]
313045
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
NIPE-LIH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernias
335268
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Condition category
Condition code
Surgery
331839
331839
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0
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Other surgery
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Anaesthesiology
331840
331840
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329596
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
339493
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Intra-operative pain
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Assessment method [1]
339493
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Newborn/Infant Parasympathetic Evaluation (NIPE) index
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Timepoint [1]
339493
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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
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Primary outcome [2]
339495
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Analgesia Requirement
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Assessment method [2]
339495
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Analgesia consumption score
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Timepoint [2]
339495
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Every 10 minutes while in PACU
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Primary outcome [3]
339494
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Post-operative pain
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Assessment method [3]
339494
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Face, Legs, Activity, Cry, Consolability (FLACC) Scale
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Timepoint [3]
339494
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Every 10 minutes while in Post-Anaesthesia Care Unit (PACU)
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Secondary outcome [1]
440191
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Time to 'ready for discharge'
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Assessment method [1]
440191
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Time from entry to PACU until ready to be discharged to home or surgical ward via audit of electronic medical records
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Timepoint [1]
440191
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At time of 'ready for discharge' from PACU
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Secondary outcome [2]
440188
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Episodes of post-operative vomiting
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Assessment method [2]
440188
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Number of episodes of post-operative vomiting recorded by the nurses in PACU.
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Timepoint [2]
440188
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Every 10 minutes while in PACU
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Secondary outcome [3]
440189
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Requirement for anti-emetic drugs
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Assessment method [3]
440189
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Medication and dose of anti-emetics administered as documented in the electronic medical record.
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Timepoint [3]
440189
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Every 10 minutes while in PACU
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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.
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Minimum age
No limit
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Maximum age
2
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will not be concealed.
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/03/2025
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Actual
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Date of last participant enrolment
Anticipated
24/10/2025
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Actual
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Date of last data collection
Anticipated
24/10/2025
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27152
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Monash Children’s Hospital - Clayton
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Recruitment postcode(s) [1]
43232
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
317486
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Hospital
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Name [1]
317486
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Monash Children's Hospital
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Address [1]
317486
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Country [1]
317486
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Australia
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Primary sponsor type
Hospital
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Name
Monash Children's Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319812
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None
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Name [1]
319812
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Address [1]
319812
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Country [1]
319812
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Other collaborator category [1]
283268
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University
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Name [1]
283268
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Monash University
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Address [1]
283268
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Country [1]
283268
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
316199
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
316199
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research@monashhealth.org
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Ethics committee country [1]
316199
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Australia
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Date submitted for ethics approval [1]
316199
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25/11/2024
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Approval date [1]
316199
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Ethics approval number [1]
316199
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Summary
Brief summary
Recently, a monitor called the Newborn Infant Parasympathetic Evaluation (NIPE) has been used to study pain in children under 2 years of age, as it assigns a numeric value to the pain response. It does this by analysing the variability of the heart rate, and studies have shown that it accurately tells us when the child is reacting to pain during surgery. For many surgeries, laparoscopic (key-hole) approaches are becoming more widely used. However, this is limited research investigating pain in laparoscopic inguinal hernia repair surgeries. We recently conducted a small study that showed that the addition Local Infiltration (anaesthetic injected into the area being operated on) may reduce pain in comparison with Caudal Block (anaesthetic injected into the base of the spine) alone. Therefore, our study aims to compare differences in pain during and after laparoscopic inguinal hernia surgery between children who receive local infiltration and children who receive caudal blocks, using the NIPE monitor. If this study is effective, it will potentially allow us to better prevent children from experiencing pain after surgery, by balancing the anaesthetic and pain medications in a more focussed way. It will also potentially clarify if one of the anaesthetic methods is associated with reduced pain during and after surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Maurizio Pacilli
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Address
137114
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Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
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Country
137114
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Australia
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Phone
137114
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+61 385723838
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Fax
137114
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Email
137114
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[email protected]
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Contact person for public queries
Name
137115
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Maurizio Pacilli
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Address
137115
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Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
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Country
137115
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Australia
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Phone
137115
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+61 385723838
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Fax
137115
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Email
137115
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[email protected]
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Contact person for scientific queries
Name
137116
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Maurizio Pacilli
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Address
137116
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Monash Children's Hospital - 246 Clayton Rd, Clayton VIC 3168
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Country
137116
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Australia
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Phone
137116
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+61 385723838
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Fax
137116
0
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Email
137116
0
[email protected]
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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.
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