Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery

Study Overview
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Brief Summary
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Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.

Detailed Description
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This single-center, prospective, single blind, randomized study will enroll up to 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.

Official Title
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The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair

Conditions
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Hydrocele, Inguinal Hernia

Intervention / Treatment
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* Procedure: TAP block
* Procedure: Local Infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 2-8 years of age Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma) Exclusion Criteria: History of allergy to study medications Enrollment in concurrent research study Pregnant patients* Students/trainees/staff* Mentally disabled/cognitively impaired*

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Group<br>Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. | Procedure: TAP block<br>* TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.<br>|
| Active Comparator: Local Infiltration Group<br>Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. | Procedure: Local Infiltration<br>* Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) | FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU. | Admission into PACU |