Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

Study Overview
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Brief Summary
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Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.

Official Title
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Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Blind Local Anesthetic infiltration
* Procedure: Transversals Fascia Block
* Procedure: Spinal Anesthesia
* Drug: Ropivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age> 18 years; ASA score I - II - III; patients undergoing elective inguinal hernia repair; signed informed consent; Exclusion Criteria: chronic therapy with opioids/ antidepressants; urgent/emergent surgery; postoperative transfer to the intensive care unit; known allergy to any drug medication; local skin infection; epilepsy; alcohol or drug abuse;

Ages Eligible for Study
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Minimum Age: 18 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: Blind Local Anesthetic Infiltration<br> | Procedure: Blind Local Anesthetic infiltration<br>* Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.<br>Drug: Ropivacaine<br>* Local anesthetic used for local infiltration and Transversals fascia block<br>|
| Active Comparator: Transversals Fascia Block<br> | Procedure: Transversals Fascia Block<br>* Patients of this group received ultrasound guided omolateral Transversals Fascia Block.<br>Drug: Ropivacaine<br>* Local anesthetic used for local infiltration and Transversals fascia block<br>|
| Active Comparator: Spinal Anesthesia<br> | Procedure: Spinal Anesthesia<br>* Patients of this group received Spinal Anesthesia<br>Drug: Bupivacaine<br>* Local anesthetic used for Spinal Anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital discharge | Time need to reach hospital discharge criteria in post-operative period | First 6 post-operative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Pain Control | Need of addiction local anesthetic or endovascular anesthetic to performed surgery | Intraoperative period | 
| Post-operative Pain | NRS score in post-operative period | Post-operative period for 6 hours, every 30 min | 
| Side effects | Incidence of side effects | intra-operative and post-operative period (6 hours) | 
| Chronic Pain | Incidence of chronic post-operative pain | at 1 week and 3 months in post-operative period |