NCT02290054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2016

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

2.1 years

First QC Date

November 8, 2014

Last Update Submit

June 7, 2017

Conditions

Analgesia, Epidural

Keywords

analgesia, epiduralurinary retention

Outcome Measures

Primary Outcomes (1)

  • bladder catheterization

    Requirement of bladder catheterization during the day and the first night following surgery

    24 hours

Secondary Outcomes (2)

  • Comfort

    24 hours

  • Anxiety

    24 hours

Study Arms (2)

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.

Procedure: ControlProcedure: Intra-venous anesthesia

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.

Procedure: TreatedProcedure: Intra-venous anesthesia

Interventions

ControlPROCEDURE

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

Also known as: Sham Comparator
Control
TreatedPROCEDURE

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

Also known as: Auriculotherapy
Treated
Intra-venous anesthesiaPROCEDURE
ControlTreated

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Foch

Suresnes, Hauts de Seine, 92151, France

Location

Related Publications (1)

  • 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.

    PMID: 31169723DERIVED

MeSH Terms

Conditions

AgnosiaUrinary Retention

Interventions

TherapeuticsAuriculotherapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies

Study Officials

  • Mireille Michel-Cherqui, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2014

First Posted

November 13, 2014

Study Start

April 1, 2014

Primary Completion

May 23, 2016

Study Completion

May 23, 2016

Last Updated

June 8, 2017

Record last verified: 2017-06

Locations

FR(1)