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RUPO: Auriculotherapy for Prevention of Postoperative Urinary Retention

Sponsor
Hopital Foch (Other)
Overall Status
Completed
CT.gov ID
NCT02290054
Collaborator
(none)
53
Enrollment
1
Location
2
Arms
25.7
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Control
  • Procedure: Treated
  • Procedure: Intra-venous anesthesia
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
May 23, 2016
Actual Study Completion Date :
May 23, 2016

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Control

A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

Procedure: Control
Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.
Other Names:
  • Sham Comparator

    • Procedure: Intra-venous anesthesia
    Experimental: Treated

    A thoracic epidural catheter is inserted first. Then total intra-venous anesthesia is performed. Auriculotherapy is performed while the patient is sleeping but before thoracic incision. Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

    Procedure: Treated
    Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
    Other Names:
  • Auriculotherapy

    • Procedure: Intra-venous anesthesia

    Outcome Measures

    Primary Outcome Measures

    1. bladder catheterization [24 hours]

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

    Secondary Outcome Measures

    1. Comfort [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 [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 "

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Foch Suresnes Hauts de Seine France 92151

    Sponsors and Collaborators

    • Hopital Foch

    Investigators

    • Principal Investigator: Mireille Michel-Cherqui, MD, Hopital Foch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hopital Foch
    ClinicalTrials.gov Identifier:
    NCT02290054
    Other Study ID Numbers:
    • 2013/41
    • 2013-A01396-39
    First Posted:
    Nov 13, 2014
    Last Update Posted:
    Jun 8, 2017
    Last Verified:
    Jun 1, 2017
    Keywords provided by Hopital Foch
    analgesia, epidural
    urinary retention
    Additional relevant MeSH terms:
    Urinary Retention
    Anesthetics

    Study Results

    No Results Posted as of Jun 8, 2017