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

Sponsor

Georgios Koukoulis (Other)

Overall Status

Completed

CT.gov ID

NCT03976934

Collaborator

University of Thessaly (Other)

100

Enrollment

Locations

Arms

20.9

Actual Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia Urinary Retention	Drug: Tamsulosin Drug: Placebo oral tablet	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital of Larissa	Larissa		Greece	41110
2	General Hospital Of Larissa	Larissa		Greece	41221

Sponsors and Collaborators

Georgios Koukoulis
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