Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.

Study Overview
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Brief Summary
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Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. One disadvantage of this combination is the high incidence of post-surgery urinary retention, especially in men above 50 years old. This complication is partially attribute to overstimulation of the a1 adrenergic receivers of the bladder and the prostate. Preoperative administration of elective a1 blockers could inhibit this effect without side effects, since this drugs don't have systemic effect.

Official Title
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Prophylactic Administration of Alpha Blockers for Prevention of Post Operative Urinary Retention in Males Undergoing Open Inguinal Hernia Repair Under Spinal Anaesthesia.

Conditions
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Inguinal Hernia, Urinary Retention

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral inguinal hernia Exclusion Criteria: ASA score >3 hypotension prostatic hypertrophy complicated inguinal hernia neurological diseases inguinal hernia repair under general or local anaesthesia

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin group<br>administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery | Drug: Tamsulosin<br>* administration of tamsulosin tablets<br>* Other names: omnic tocas;|
| Placebo Comparator: Placebo group<br>administration of placebo 24 and 6 hours before surgery | Drug: Placebo oral tablet<br>* sugar pills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of urinary retention | inability to voluntarily void urine up to 8 hours post surgery | 8 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate related Symptoms | identification of Prostate related Symptoms as preoperative risk factor of post surgery urinary retention. For the assessment of the prostate related symptomatology will be used the International Prostate Symptom Score questionnaire | Baseline | 
| Scrotal hernia Repair | evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention. | Baseline, Inta-operative | 
| Duration of Surgery | Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention. | Duration of Surgical procedure | 
| Use of opioids | Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention. | 24 hours | 
| Iv fluid administration | Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention. | 24 hours | 
| Post-operative Pain | Evaluation of the post operative pain as a risk factor of post surgery urinary retention. For the assessment of the pain will be used the Visual Analog Scale (VAS) score at 6, 12 and 24 hours after surgery. (VAS Score Scale from 0-10, 0 no pain, 10 max pain) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open inguinal hernia repair, spinal anaesthesia, urinary retention, elective alpha blockers