Clinical trial NCT03976934: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Inguinal Hernia
Urinary Retention
Keywords: open inguinal hernia repair
spinal anaesthesia
urinary retention
elective alpha blockers
Lead sponsor: General Hospital of Larissa
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2019-06-06
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: incidence of urinary retention
timeFrame: 8 hours post surgery
Secondary outcomes:
measure: Prostate related Symptoms
timeFrame: Baseline
measure: Scrotal hernia Repair
timeFrame: Baseline, Inta-operative
measure: Duration of Surgery
timeFrame: Duration of Surgical procedure
measure: Use of opioids
timeFrame: 24 hours
measure: Iv fluid administration
timeFrame: 24 hours
measure: Post-operative Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Larissa
country: Greece
facility: General Hospital Of Larissa
Study officials:
affiliation: University Hospital of Larisa and Medical School, University of Thessaly
name: Konstantinos Tepetes, MD, PHD
role: STUDY_CHAIR
affiliation: General Hospital of Larissa
name: Georgios D Koukoulis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Larissa
name: Konstantinos Mpouliaris, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.