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

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976934
• Other study ID #: 1725
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: General Hospital of Larissa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 30, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Urinary Retention

Intervention

Drug:
• Tamsulosin
administration of tamsulosin tablets
• Placebo oral tablet
sugar pills

Locations

Country	Name	City	State
Greece	General Hospital Of Larissa	Larissa
Greece	University General Hospital of Larissa	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
Georgios Koukoulis	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of urinary retention	inability to voluntarily void urine up to 8 hours post surgery	8 hours post surgery
Secondary	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
Secondary	Scrotal hernia Repair	evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.	Baseline, Inta-operative
Secondary	Duration of Surgery	Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.	Duration of Surgical procedure
Secondary	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
Secondary	Iv fluid administration	Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.	24 hours
Secondary	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