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

NCT ID: NCT03976934

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-10-30

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.

Detailed Description

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Conditions

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Inguinal Hernia Urinary Retention

Keywords

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open inguinal hernia repair spinal anaesthesia urinary retention elective alpha blockers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tamsulosin group

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

Group Type ACTIVE_COMPARATOR

Tamsulosin

Intervention Type DRUG

administration of tamsulosin tablets

Placebo group

administration of placebo 24 and 6 hours before surgery

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

sugar pills

Interventions

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Tamsulosin

administration of tamsulosin tablets

Intervention Type DRUG

Placebo oral tablet

sugar pills

Intervention Type DRUG

Other Intervention Names

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omnic tocas

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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role collaborator

Georgios Koukoulis

OTHER

Sponsor Role lead

Responsible Party

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Georgios Koukoulis

General Surgery Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Konstantinos Tepetes, MD, PHD

Role: STUDY_CHAIR

University Hospital of Larisa and Medical School, University of Thessaly

Georgios D Koukoulis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Larissa

Konstantinos Mpouliaris, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Larissa

Locations

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University General Hospital of Larissa

Larissa, , Greece

Site Status

General Hospital Of Larissa

Larissa, , Greece

Site Status

Countries

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Greece

References

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Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.

Reference Type BACKGROUND
PMID: 28341140 (View on PubMed)

Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.

Reference Type BACKGROUND
PMID: 28584678 (View on PubMed)

Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.

Reference Type BACKGROUND
PMID: 25935942 (View on PubMed)

Other Identifiers

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1725

Identifier Type: -

Identifier Source: org_study_id