Comparison of a Bilateral TAP Block and Preperitoneal Instillation of Local Anesthetic for a Total Extraperitoneal (TEP) Repair

Study Overview
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Brief Summary
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Comparison of an ultrasound guided bilateral TAP (transversus abdominis plane) block with dexamethasone and preperitoneal instillation of local anesthetic with dexamethasone under direct visualization will be compared it to a standard anesthetic technique (control) following a TEP (total extraperitoneal) bilateral hernia repair. The investigators are hypothesizing that the bilateral TAP block and preperitoneal instillation of local anesthetics with the addition of dexamethasone are superior in terms of patient satisfaction and post-operative pain control when compared to a standard anesthetic technique (no regional technique).

Official Title
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Comparison of an Ultrasound Guided Bilateral Transversus Abdominis Plane Block With Dexamethasone and Preperitoneal Instillation of Local Anesthetic With Dexamethasone to a Standard Anesthetic Technique for Analgesic Efficacy and Patient Satisfaction Following a Total Extraperitoneal Bilateral Inguinal Hernia Repair: A Prospective Randomized Single Blinded Study

Conditions
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Bilateral Inguinal Hernia Repair

Intervention / Treatment
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* Procedure: Transversus abdominis plane block (TAP BLOCK)
* Procedure: Instillation of surgical site with local anesthetic.
* Procedure: Opioid IV medications (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 yrs of age American Society of Anesthesiologists (ASA) physical status 1-3 Scheduled for outpatient TEP bilateral inguinal hernia repair Exclusion Criteria: Patients refusal to participate inability to give consent drug allergies to medications used in study pregnancy bleeding diathesis conversion to an open procedure any subject whose anatomy, or surgical procedure, in the opinion of the investigator might preclude the potential successful performance of a TAP block any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound guided bilateral TAP block<br>Ultrasound guided TAP Block with local anesthetic and dexamethasone. | Procedure: Transversus abdominis plane block (TAP BLOCK)<br>* Ultrasound guided TAP block with local anesthetics and dexamethasone.<br>|
| Active Comparator: Instillation of surgical site with local anesthestic.<br>Instillation of surgical site under direct visualization with local anesthetics and dexamethasone. | Procedure: Instillation of surgical site with local anesthetic.<br>* Instillation of surgical site with local anesthetics and dexamethasone.<br>|
| Placebo Comparator: Control Group<br>Standard anesthetic technique | Procedure: Opioid IV medications (Control)<br>* Standard anesthetic technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Assessment will be done postoperatively using a Quality of Recovery 40 (QoR-40) questionnaire after surgery. | Post-operatively (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Total opioid use in the post anesthesia care unit (PACU) and the period following surgery. | Post-operatively (Day 0 to 1) | 
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Pain scores in the PACU | Post-operatively (day 0) | 
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Pain scores post-operatively. | Post-operatively (day 1) | 
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Any side effects secondary to any of the post-operative pain procedures. | Post-operatively (day 0 to 1) | 
| Assess the efficacy of a bilateral TAP block and preperitoneal instillation of local anesthetic to a standard anesthetic technique for TEP hernia repair | Time spent in the PACU | Post-operatively (day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Ultrasound guided, Bilateral Transversus abdominis Plane Block, Preperitoneal Instillation, Local Analgesic, Efficacy, Total Extraperitoneal Bilateral Inguinal hernia repair