Comparison of Two Different Pain Management Techniques in Pediatric Patients Undergoing a Hernia Repair

Study Overview
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Brief Summary
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The purpose of this research study is to find the best way to decrease pain in children right after surgery whom have had their hernia fixed. Right now, there are two different ways surgeons and anesthesia providers try to decrease pain. It is not clear if one way is better than the other. The method used is often chosen by which one the doctor has more experience using. The Investigator plans to find out if one of the methods is more effective and/or safer than the other method. The results of this study will help learn how to best control pain in children having surgery for hernia repair.

Detailed Description
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Unilateral inguinal herniorrhaphy is a commonly performed surgical procedure in the pediatric population. Multimodal anesthesia consisting of systemic narcotics, surgical wound infiltration with local anesthetic and ilioinguinal and/or iliohypogastric nerve blockade has traditionally been employed to achieve acceptable analgesia. Recently, ultrasound-based studies have demonstrated that blind abdominal wall injections are done with poor accuracy. Ultrasound-guided alternatives, such as the transverses abdominis plane (TAP) block, may improve analgesic efficacy and patient comfort in the post-operative period when compared to blind landmark based nerve blockade. There has been increasing utilization of the TAP block in the adult population due to the described ability to provide effective blockade of the thoracolumbar spinal nerves innervating the abdominal wall. We propose a randomized prospective evaluation of the analgesic efficacy comparing surgeon performed ilioinguinal/iliohypogastric block with ultrasound-guided TAP blockade in healthy ASA I and II pediatric patients undergoing unilateral herniorrhaphy on an outpatient basis.

Official Title
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Randomized Prospective Comparison of Analgesic Efficacy of Surgeon Performed IIlioinguinal/Iliohypogastric Blockade With Ultrasound-Guided TAP Blockade in Pediatric Patients Undergoing Unilateral Herniorrhaphy on an Outpatient Basis

Conditions
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Pain, Inguinal Hernia

Intervention / Treatment
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* Procedure: TAP Block
* Procedure: Ilioinguinal/iliohypogastric blockade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is male or female; The subject is of any racial and ethnic groups; The subject is age 12 months to 10 years (inclusive); The subject weighs more than 8.0 kg (inclusive of the eighth kilogram); The subject is scheduled for the following: Unilateral herniorrhaphy scheduled on an out-patient basis, and not being performed in conjunction with any other surgical procedures; The subject is American Society of Anesthesiologists (ASA) patient classification I-II The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate. Exclusion Criteria: Additional surgical procedures are being performed concurrently; The subject is ASA classification > II; The subject has pre-existing allergies to local anesthetics; The subject receives midazolam as a premedication; The subject has an imminent life threatening condition that impacts the ability to obtain informed consent; The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block<br> | Procedure: TAP Block<br>* While the terminal branches of T7 to L1 cannot be visualized under ultrasound as they pass between the internal oblique and the transverse abdominis muscles, they are expected to lie within this plane. The three muscular layers of the abdominal wall, however, can be easily identified under ultrasound guidance. A needle is advanced under ultrasound guidance towards the fascial plane that separates the internal oblique and the transversus abdominis muscles, at which point local anesthetic is deposited under direct visualization.<br>* Other names: transversus abdominis plane block;|
| Active Comparator: Ilioinguinal/iliohypogastric blockade<br> | Procedure: Ilioinguinal/iliohypogastric blockade<br>* Ilioinguinal and iliohypogastric blockade is performed as an injection after palpation of the anterior superior iliac spine followed be a perceived loss of resistance with insertion of the needle, or may be infiltrated locally following herniorrhaphy exposure as anatomic landmarks can prove to be difficult to locate in the anesthetized pediatric patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcome | Worst FLACC score observed in the post-anesthesia care unit by the research coordinator during the first post-operative hour | Participants will be followed for the duration of post-anesthesia care unit stay, an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcome - Length of Recovery Room | time required for the patient to meet discharge criteria | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours | 
| Confounding Variable - Electrocautery | whether or not cautery was used as a measure of surgical technique | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours | 
| Confounding Variable - Surgical dissection | length of surgical procedure as an indicator of the extent of surgical dissection performed | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours | 
| Confounding Variable - Length of time for TAP | length of time required to perform TAP block | participants will be followed for the length of the surgical procedure, an expected average of 1.5 hours | 
| Efficacy Outcome - Post-operative Calls | Phone calls made to surgeons regarding parental concern of post-operative pain forty-eight hours post-operatively | participants will be followed for 48 hours after procedure | 
| Outcome Measure - Number of patients with post-operative complications | presence of post-operative complications | participants will be followed for 48 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Regional Anesthesia, ultrasound, transversus abdominis plane, herniorrhaphy, pediatrics