Auriculotherapy for Prevention of Postoperative Urinary Retention (RUPO)

June 7, 2017 updated by: Hopital Foch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts de Seine
      • Suresnes, Hauts de Seine, France, 92151
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Intra-venous anesthesia
Procedure: Treated
Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
Other Names:
  • Auriculotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bladder catheterization
Time Frame: 24 hours
Requirement of bladder catheterization during the day and the first night following surgery
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 "
24 hours
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 "
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 23, 2016

Study Completion (Actual)

May 23, 2016

Study Registration Dates

First Submitted

November 8, 2014

First Submitted That Met QC Criteria

November 8, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/41
  • 2013-A01396-39 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe