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

Georgios Koukoulis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Retention; Inguinal Hernia

Treatments: Drug: Placebo oral tablet; Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT03976934

1725

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Tamsulosin group

Active Comparator group

Description:

administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery

Treatment:

Drug: Tamsulosin

Placebo group

Placebo Comparator group

Description:

administration of placebo 24 and 6 hours before surgery

Treatment:

Drug: Placebo oral tablet