Auriculotherapy for Prevention of Postoperative Urinary Retention

Study Overview
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Brief Summary
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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.

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

Conditions
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Analgesia, Epidural

Intervention / Treatment
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* Procedure: Control
* Procedure: Treated
* Procedure: Intra-venous anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>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<br>* Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.<br>* Other names: Sham Comparator;Procedure: Intra-venous anesthesia<br> <br> |
| Experimental: Treated<br>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<br>* Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.<br>* Other names: Auriculotherapy;Procedure: Intra-venous anesthesia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder catheterization | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, epidural, urinary retention