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Completed

NCT Number: NCT02290054

Auriculotherapy for Prevention of Postoperative Urinary Retention

Urinary retention is a common complication of epidural analgesia. Auriculotherapy could prevent this complication. This study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.

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Key information

Conditions

Analgesia, Epidural Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Foch

Suresnes, Hauts de Seine, 92151, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled to a lung surgical procedure and thoracic epidural analgesia

Exclusion criteria

  • Abnormalities of the external ear
  • Dialysis or end stage renal failure
  • Abnormal urinary tract
  • Incapacity to self assessment of comfort and anxiety,
  • Contra-indication to total intravenous anesthesia

Treatment and study plan

Control

Procedure

Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

Other names: Sham Comparator

Treated

Procedure

Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

Other names: Auriculotherapy

Intra-venous anesthesia

Procedure

Primary outcomes

  1. bladder catheterization

    Time frame: 24 hours

    Requirement of bladder catheterization during the day and the first night following surgery

Secondary outcomes

  1. Comfort

    Time frame: 24 hours

    The degree of patient's comfort is assessed six hours after his arrival in the recovery room and the morning after surgery using a numerical scale from 0 '"maximum discomfort " to 10" maximum comfort "

  2. Anxiety

    Time frame: 24 hours

    The degree of patient's anxiety is assessed six hours after his arrival in the recovery room and the morning after surgery using a numerical scale from 0 '"maximum discomfort " to 10" maximum comfort "

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery

Acronym: RUPO

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2014
Registry last updated
Jun 8, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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