Back to resultsAuriculotherapy for Prevention of Postoperative Urinary Retention (RUPO)
Primary Purpose
Analgesia, Epidural
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Control
Treated
Intra-venous anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Analgesia, Epidural focused on measuring analgesia, epidural, urinary retention
Eligibility 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
Sites / Locations
- Hôpital Foch
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control
Treated
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
bladder catheterization
Requirement of bladder catheterization during the day and the first night following surgery
Secondary Outcome Measures
Comfort
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 "
Anxiety
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 "
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02290054
Brief Title
Auriculotherapy for Prevention of Postoperative Urinary Retention
Acronym
RUPO
Official Title
Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 23, 2016 (Actual)
Study Completion Date
May 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Epidural
Keywords
analgesia, epidural, urinary retention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Treated
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Other Intervention Name(s)
Sham Comparator
Intervention Description
Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.
Intervention Type
Procedure
Intervention Name(s)
Treated
Other Intervention Name(s)
Auriculotherapy
Intervention Description
Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
Intervention Type
Procedure
Intervention Name(s)
Intra-venous anesthesia
Primary Outcome Measure Information:
Title
bladder catheterization
Description
Requirement of bladder catheterization during the day and the first night following surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comfort
Description
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 "
Time Frame
24 hours
Title
Anxiety
Description
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 "
Time Frame
24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Foch
City
Suresnes
State/Province
Hauts de Seine
ZIP/Postal Code
92151
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31169723
Citation
Michel-Cherqui M, Szekely B, Lemoyne F, Feliot E, Gayat E, Fischler M. Auriculotherapy in the prevention of postoperative urinary retention in patients with thoracotomy and thoracic epidural analgesia: A randomized, double-blinded trial. Medicine (Baltimore). 2019 Jun;98(23):e15958. doi: 10.1097/MD.0000000000015958.
Results Reference
derived
Learn more about this trial
Auriculotherapy for Prevention of Postoperative Urinary Retention
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