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

Phase 1

Completed

• Conditions: Inguinal Hernia; Urinary Retention
• Interventions: Drug: Placebo oral tablet; Drug: Tamsulosin

• Registration Number: NCT03976934
• Lead Sponsor: Georgios Koukoulis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2020-02-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo oral tablet	administration of placebo 24 and 6 hours before surgery
Tamsulosin group	Tamsulosin	administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery

Primary Outcome Measures

Name	Time	Method
incidence of urinary retention	8 hours post surgery	inability to voluntarily void urine up to 8 hours post surgery

Secondary Outcome Measures

Name	Time	Method
Iv fluid administration	24 hours	Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.
Duration of Surgery	Duration of Surgical procedure	Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.
Prostate related Symptoms	Baseline	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
Use of opioids	24 hours	Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.
Post-operative Pain	24 hours	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)
Scrotal hernia Repair	Baseline, Inta-operative	evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.

Trial Locations

Locations (2)

General Hospital Of Larissa; 🇬🇷 Larissa, Greece

University General Hospital of Larissa; 🇬🇷 Larissa, Greece