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NCT Number: NCT03976934

Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing 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.

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Key information

Conditions

Inguinal Hernia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hernia Hernia, Abdominal Hernia, Inguinal Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

General Hospital Of Larissa, Larissa, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

administration of tamsulosin tablets

Other names: omnic tocas

Placebo oral tablet

Drug

sugar pills

Primary outcomes

  1. incidence of urinary retention

    Time frame: 8 hours post surgery

    inability to voluntarily void urine up to 8 hours post surgery

Secondary outcomes

  1. Prostate related Symptoms

    Time frame: 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

  2. Scrotal hernia Repair

    Time frame: Baseline, Inta-operative

    evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.

  3. Duration of Surgery

    Time frame: Duration of Surgical procedure

    Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.

  4. Use of opioids

    Time frame: 24 hours

    Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.

  5. Iv fluid administration

    Time frame: 24 hours

    Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.

  6. Post-operative Pain

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Georgios Koukoulis

Other

Collaborators

  • University of Thessaly

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2019
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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