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

Primary Purpose

Inguinal Hernia, Urinary Retention

Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Tamsulosin
Placebo oral tablet
Sponsored by
Georgios Koukoulis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring open inguinal hernia repair, spinal anaesthesia, urinary retention, elective alpha blockers

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • University General Hospital of Larissa
  • General Hospital Of Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamsulosin group

Placebo group

Arm Description

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

administration of placebo 24 and 6 hours before surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Scrotal hernia Repair
evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.
Duration of Surgery
Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.
Use of opioids
Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.
Iv fluid administration
Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.
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)

Full Information

First Posted
May 31, 2019
Last Updated
November 23, 2021
Sponsor
Georgios Koukoulis
Collaborators
University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT03976934
Brief Title
Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.
Official Title
Prophylactic Administration of Alpha Blockers for Prevention of Post Operative Urinary Retention in Males Undergoing Open Inguinal Hernia Repair Under Spinal Anaesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Georgios Koukoulis
Collaborators
University of Thessaly

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Urinary Retention
Keywords
open inguinal hernia repair, spinal anaesthesia, urinary retention, elective alpha blockers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin group
Arm Type
Active Comparator
Arm Description
administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
administration of placebo 24 and 6 hours before surgery
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
omnic tocas
Intervention Description
administration of tamsulosin tablets
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
sugar pills
Primary Outcome Measure Information:
Title
incidence of urinary retention
Description
inability to voluntarily void urine up to 8 hours post surgery
Time Frame
8 hours post surgery
Secondary Outcome Measure Information:
Title
Prostate related Symptoms
Description
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
Time Frame
Baseline
Title
Scrotal hernia Repair
Description
evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.
Time Frame
Baseline, Inta-operative
Title
Duration of Surgery
Description
Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.
Time Frame
Duration of Surgical procedure
Title
Use of opioids
Description
Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.
Time Frame
24 hours
Title
Iv fluid administration
Description
Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.
Time Frame
24 hours
Title
Post-operative Pain
Description
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)
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Tepetes, MD, PHD
Organizational Affiliation
University Hospital of Larisa and Medical School, University of Thessaly
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Georgios D Koukoulis, MD, PhD
Organizational Affiliation
General Hospital of Larissa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Konstantinos Mpouliaris, MD
Organizational Affiliation
General Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
General Hospital Of Larissa
City
Larissa
ZIP/Postal Code
41221
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28341140
Citation
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.
Results Reference
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PubMed Identifier
28584678
Citation
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.
Results Reference
background
PubMed Identifier
25935942
Citation
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.
Results Reference
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Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.

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