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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03976934

Enrollment

100

Registered

2019-06-06

Start date

2020-02-01

Completion date

2021-10-30

Last updated

2021-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Urinary Retention

Keywords

open inguinal hernia repair, spinal anaesthesia, urinary retention, elective alpha blockers

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.

Interventions

DRUGTamsulosin

administration of tamsulosin tablets

DRUGPlacebo oral tablet

sugar pills

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
incidence of urinary retention	8 hours post surgery	inability to voluntarily void urine up to 8 hours post surgery

Secondary

Measure	Time frame	Description
Scrotal hernia Repair	Baseline, Inta-operative	evaluation of Scrotal hernia repair as preoperative 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
Iv fluid administration	24 hours	Evaluation of the peri-operative iv fluid administration 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)
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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026