Auriculotherapy for Prevention of Postoperative Urinary Retention

Analgesia, Epidural Clinical Trial

— RUPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290054
• Other study ID #: 2013/41
• Secondary ID: 2013-A01396-39
• Status: Completed
• Phase: N/A
• First received: November 8, 2014
• Last updated: June 7, 2017
• Start date: April 2014
• Est. completion date: May 23, 2016

Study information

• Verified date: June 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 23, 2016
• Est. primary completion date: May 23, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia, Epidural
• Urinary Retention

Intervention

Procedure:
• Control
Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.
• Treated
Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
• Intra-venous anesthesia

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes	Hauts de Seine

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bladder catheterization	Requirement of bladder catheterization during the day and the first night following surgery	24 hours
Secondary	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 "	24 hours
Secondary	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 "	24 hours