Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Auriculotherapy for Prevention of Postoperative Urinary Retention (RUPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02290054
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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
Analgesia, Epidural Procedure: Control Procedure: Treated Procedure: Intra-venous anesthesia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : May 23, 2016
Actual Study Completion Date : May 23, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Auriculotherapy

Procedure: Intra-venous anesthesia



Primary Outcome Measures :
  1. bladder catheterization [ Time Frame: 24 hours ]
    Requirement of bladder catheterization during the day and the first night following surgery


Secondary Outcome Measures :
  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 "



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290054


Locations
Layout table for location information
France
Hôpital Foch
Suresnes, Hauts de Seine, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Layout table for investigator information
Principal Investigator: Mireille Michel-Cherqui, MD Hopital Foch

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02290054     History of Changes
Other Study ID Numbers: 2013/41
2013-A01396-39 ( Other Identifier: ANSM )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Hopital Foch:
analgesia, epidural
urinary retention

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Retention
Urination Disorders
Urologic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs