Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh

Study Overview
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Brief Summary
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To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia Repair Mesh

Detailed Description
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This study will be: controlled, prospective, randomized and double blind. Randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. At the time of admission to the study, they were assigned randomly to one of the two branches of intervention: (Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml. (Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml. Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days . It will also evaluate analgesic consumption, complications and labor return

Official Title
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Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine-Dexamethasone
* Drug: Bupivacaine- physiological solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years. Unilateral inguinal hernioplasty. That the surgery is performed in the Ambulatory Surgery Unit (UCA). Exclusion Criteria: Recurrent hernia. allergies, ongoing infections, diabetes. Background of rejection of prosthetic material (mesh).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine-Dexamethasone<br>bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml | Drug: Bupivacaine-Dexamethasone<br>* Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg<br>|
| Active Comparator: Bupivacaine- physiological solution<br>bupivacaine 1,5 mg/kg + physiological solution | Drug: Bupivacaine- physiological solution<br>* Bupivacaine 1,5 mg/kg- physiological solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain postoperative | It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| take analgesic | Medication journal completed by patient | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, hernia repair, Dexamethasone