Auriculotherapy for Prevention of Postoperative Urinary Retention

NCT ID: NCT02290054

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-23

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.

Detailed Description

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Conditions

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Analgesia, Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

Intra-venous anesthesia

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Treated

Intervention Type PROCEDURE

Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

Intra-venous anesthesia

Intervention Type PROCEDURE

Interventions

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Control

Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.

Intervention Type PROCEDURE

Treated

Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.

Intervention Type PROCEDURE

Intra-venous anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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Sham Comparator Auriculotherapy

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mireille Michel-Cherqui, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hôpital Foch

Suresnes, Hauts de Seine, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 31169723 (View on PubMed)

Other Identifiers

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2013-A01396-39

Identifier Type: OTHER

Identifier Source: secondary_id

2013/41

Identifier Type: -

Identifier Source: org_study_id

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