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Pain in Open and Laparoscopic Hernia Operation: POLHO Study

Evaluation of the pain response in infants undergoing open and laparoscopic inguinal hernia repair under general anaesthesia using newborn infant parasympathetic evaluation (NIPE).

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000232639
Acronym
POLHO
Enrollment
40
Registered
2023-03-06
Start date
2023-03-27
Completion date
2023-09-29
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will explore whether intraoperative pain measured with the NIPE monitor correlates to the level of postoperative pain and the amount of analgesia required after elective laparoscopic and open inguinal hernia repair. This could clarify if laparoscopic inguinal hernia repair is associated with reduced intraoperative and postoperative pain leading to a reduction of postoperative analgesia and length of hospital stay. This has not yet been explored and this may ultimately result in less pain and distress to children and their carers, and also reduce healthcare costs.

Interventions

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 can

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.

Sponsors

Monash Children's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to 2 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026