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Trial registered on ANZCTR


Registration number
ACTRN12623000232639p
Ethics application status
Submitted, not yet approved
Date submitted
23/02/2023
Date registered
6/03/2023
Date last updated
6/03/2023
Date data sharing statement initially provided
6/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain in Open and Laparoscopic Hernia Operation: POLHO Study
Scientific title
Evaluation of the pain response in infants undergoing open and laparoscopic inguinal hernia repair under general anaesthesia using newborn infant parasympathetic evaluation (NIPE).

Secondary ID [1] 308970 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
POLHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 329131 0
Inguinal hernia 329132 0
Condition category
Condition code
Anaesthesiology 326109 326109 0 0
Pain management
Surgery 326110 326110 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children will undergo standardised inguinal hernia surgery according to local guidelines and practice. Children will undergo standardised anaesthesia.

The NIPE monitor will be connected to the electrocardiogram monitor, to analyse the heart rate variability (and thus parasympathetic tone), producing a value correlating to pain. We will be documenting the median intraoperative NIPE value, as well as the absolute values at the following specified time points: endotracheal intubation, venous cannulation, peripheral nerve block administration, skin incision, and skin closure.

Following these procedures, post-operative outcomes measures will be assessed including continued monitoring via the NIPE monitor and a questionnaire completed by clinical staff at 30 minute intervals. Patients will be observed from entering the post anaesthetic care unit until discharge home or to the surgical ward upon meeting criteria according to local guidelines.

The NIPE monitor is an adjunct to standard monitoring with an electrocardiogram monitor. It is a non-invasive method of monitoring that analyses data from the electrocardiogram monitor. Standard electrocardiogram monitoring involves the placement of external electrodes on the body to measure electrical activity from the heart.
Intervention code [1] 325514 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333977 0
Post-operative pain; assessed as a composite primary outcome by the NIPE monitor, Numeric Rating scale (0 = no pain, 10 worst pain) and the validated FLACC Behavioural scale.

The FLACC Behavioural scale is Scored from 0-10, each component scored from 0-2.
Face
0: No particular expression or smile
1: Occasional grimace or frown, withdrawn, disinterested
2: Frequent to constant quivering chin, clenched jaw
Legs
0: Normal position or relaxed
1: Uneasy, restless, tense
2: Kicking or legs drawn up
Activity
0: Lying quietly, normal position, moves easily
1: Squirming, shifting back and forth, tense
2: Arched, rigid, or jerking
Cry
0: No cry (awake or asleep)
1: Moans or whimpers, occasional complaint
2: Crying steadily, screams or sobs, frequent complaints
Consolability
0: Content, relaxed
1: Reassured by occasional touching, hugging, or being talked to; distractible
2: Difficult to console or comfort
Timepoint [1] 333977 0
Post-operative period until discharged from the post anaesthesia care unit, assessed at 30 minute intervals.
Primary outcome [2] 333978 0
Analgesic requirement; assessed by the analgesic consumption score

This will be retrospectively collected from study-specific outcome questionnaires, or hospital records.

The analgesic consumption score will score the type of analgesic like the following:
No analgesia - 0
Non opioid (paracetamol, non-steroidal anti-inflammatory) plus/minus adjuvant - 1
Weak opioid plus/minus non opioid plus/minus adjuvant - 2
Strong opioid plus/minus non opioid plus/minus adjuvant - 3
Timepoint [2] 333978 0
Post-operative period until discharge from the post anaesthesia care unit
Secondary outcome [1] 418925 0
Post operative nausea; assessed by anti-emetic requirement and number of vomits
This will be retrospectively collected from study-specific outcome questionnaires, or hospital records
Timepoint [1] 418925 0
Post-operative period until discharge from post anaesthetic care unit
Secondary outcome [2] 418926 0
Time to discharge (from entering recovery until discharged home or to the surgical ward).
This will be retrospectively collected from study-specific outcome questionnaires, or hospital records
Timepoint [2] 418926 0
Post-operative period until discharge from post anaesthetic care unit

Eligibility
Key inclusion criteria
All children below 2 years of age, with no significant associated co-morbidities (American Society of Anaesthesiologists class 1 and 2), who are undergoing elective laparoscopic or open inguinal hernia repair will be included.
Minimum age
0 Years
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 those with a history of premature delivery, as these will interfere with the heart rate variability, pain response and therefore the NIPE value.

Ex-preterm infants unsuitable to receive general anaesthesia and undergoing open inguinal hernia repair under spinal anaesthesia will be excluded. Patients under maintenance anaesthesia with Remifentanil and Propofol-based total intravenous anaesthesia (TIVA) will be excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The proposed sample size is forty children. As no data is available in the literature to statistically determine it, this number of patients has been chosen based off the feasibility of the study to be completed in one year. Approximately 10 children in this age group undergo elective surgery every month. Accounting for a standard recruitment rate of 60%, it is anticipated that it will take a maximum of 7 months to recruit the required sample size

Results will be analysed after data extraction with dedicated statistical software (GraphPad Prism 8, MedCalc 19). Data will be expressed as mean ± SD, median (range), interquartile range (IQR), count number, or percentages, as indicated. The D’Agostino and Pearson normality test will be used to evaluate the normal distribution of continuous variables. Unpaired Student’s t, Mann–Whitney U, Chi-squares, or Fischer’s exact test will be used where appropriate to identify differences between the two groups for continuous or categorical variables. Correlation analysis will be conducted to investigate the relationship between the intraoperative NIPE index and post-operative pain with analgesia requirements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24128 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 39637 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313186 0
Hospital
Name [1] 313186 0
Monash Children's Hospital
Country [1] 313186 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 314896 0
None
Name [1] 314896 0
Address [1] 314896 0
Country [1] 314896 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312420 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 312420 0
Ethics committee country [1] 312420 0
Australia
Date submitted for ethics approval [1] 312420 0
17/01/2023
Approval date [1] 312420 0
Ethics approval number [1] 312420 0

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

Contacts
Principal investigator
Name 124598 0
Dr Maurizio Pacilli
Address 124598 0
Department of Paediatric Surgery,
Level 5, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 124598 0
Australia
Phone 124598 0
+61 385723837
Fax 124598 0
Email 124598 0
maurizio.pacilli@monash.edu
Contact person for public queries
Name 124599 0
Mahesh Sakthivel
Address 124599 0
Department of Paediatric Surgery,
Level 5, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 124599 0
Australia
Phone 124599 0
+61 385723837
Fax 124599 0
Email 124599 0
msak0014@student.monash.edu
Contact person for scientific queries
Name 124600 0
Maurizio Pacilli
Address 124600 0
Department of Paediatric Surgery,
Level 5, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 124600 0
Australia
Phone 124600 0
+61 385723837
Fax 124600 0
Email 124600 0
maurizio.pacilli@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.