None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 2 Years
Healthy volunteers
No
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.
Exclusion criteria
Patients who have cardiac, respiratory or neurological conditions will be excluded, as well as premature babies below 46 weeks post-conceptional age.
Outcome results
None listed