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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01396-39 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | 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. |
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| Treated | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Procedure | Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| bladder catheterization | Requirement of bladder catheterization during the day and the first night following surgery | 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mireille Michel-Cherqui, MD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Foch | Suresnes | Hauts de Seine | 92151 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169723 | Derived | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055097 | Auriculotherapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
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| Treated | Procedure | Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles. |
|
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| Intra-venous anesthesia | Procedure |
|
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |