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.

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Urinary Retention
• Intervention / Treatment: Drug: Tamsulosin; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41110
    • University General Hospital of Larissa
  • Larissa, Greece, 41221
    • General Hospital of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Georgios Koukoulis
• Collaborators: University of Thessaly
• Investigators: Study Chair: Konstantinos Tepetes, MD, PHD, University Hospital of Larisa and Medical School, University of Thessaly; Principal Investigator: Georgios D Koukoulis, MD, PhD, General Hospital of Larissa; Principal Investigator: Konstantinos Mpouliaris, MD, General Hospital of Larissa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: spinal anaesthesia; urinary retention; open inguinal hernia repair; elective alpha blockers
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 1725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No