Analgesia, EpiduralRUPONCT02290054
Auriculotherapy for Prevention of Postoperative Urinary Retention
A study testing Treated and Intra-venous anesthesia in people with Analgesia, Epidural, run by Hopital Foch at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Treated and Intra-venous anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to 23 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to a lung surgical procedure and thoracic epidural analgesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery
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.
- Conditions
- Analgesia, Epidural
- Being tested
- Control, Treated, Intra-venous anesthesia
- Keywords
- analgesia, epidural, urinary retention
- Medical subject headings
- Agnosia, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Also called Sham Comparator
Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.
TreatedProcedure or surgery
Also called Auriculotherapy
Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
Intra-venous anesthesiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Control; Procedure: 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. Receives: Procedure: Treated; Procedure: Intra-venous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder catheterization
Requirement of bladder catheterization during the day and the first night following surgery
Measured: 24 hours
Secondary outcomes (2)
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 "
Measured: 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 "
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startApr 2014
- Primary completion23 May 2016
- Study completion23 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mireille Michel-Cherqui, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290054
- Sponsor's protocol ID
- 2013/41
- Other IDs
- 2013-A01396-39
- Acronym
- RUPO
- Status last verified
- Jun 2017
- First submitted
- 8 Nov 2014
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31169723
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auriculotherapy for Prevention of Postoperative Urinary Retention in Men Receiving Postoperative Epidural Analgesia After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02290054
- Acronym / sponsor ID
- RUPO / 2013/41
- Conditions
- Analgesia, Epidural
- Keywords
- analgesia, epidural, urinary retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 23 May 2016 (actual)
- Study completion
- 23 May 2016 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: Control, Procedure: Intra-venous anesthesiaA 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 | Experimental | Procedure: Treated, Procedure: Intra-venous anesthesiaA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to a lung surgical procedure and thoracic epidural analgesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: Sham ComparatorImplementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision. | Procedure or surgery | Control |
| TreatedAlso: AuriculotherapyAuriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles. | Procedure or surgery | Treated |
| Intra-venous anesthesia | Procedure or surgery | Control, Treated |
Primary outcome
bladder catheterization
Time frame: 24 hours
Requirement of bladder catheterization during the day and the first night following surgery
2 secondary outcomes
Comfort
Time frame: 24 hours
Anxiety
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 31169723Michel-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireille Michel-Cherqui, MD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treated and Intra-venous anesthesia in people with Analgesia, Epidural, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bladder catheterization (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.