Auriculotherapy for Prevention of Postoperative Urinary Retention

Not Applicable

Completed

• Conditions: Analgesia, Epidural
• Interventions: Procedure: Treated; Procedure: Control; Procedure: Intra-venous anesthesia

• Registration Number: NCT02290054
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-08
• Study First Submitted QC: 2014-11-08
• Study First Posted: 2014-11-13
• Primary Completion: 2016-05-23
• Study Completion: 2016-05-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

Inclusion Criteria

• patients scheduled to a lung surgical procedure and thoracic epidural analgesia

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated	Intra-venous anesthesia	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.
Control	Intra-venous anesthesia	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.
Treated	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
bladder catheterization	24 hours	Requirement of bladder catheterization during the day and the first night following surgery

Secondary Outcome Measures

Name	Time	Method
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 "
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 "

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, Hauts de Seine, France