Labor, ObstetricPERIDANSNCT02551354
Estimation of Pain During Epidural Analgesia During Labor
A study testing Portable video pupillometer in people with Labor, Obstetric and Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor, Obstetric, Pain
- What is being tested?
- Portable video pupillometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Mar 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obstetrical Labor
- Able to rate their pain using VAS
- dilatation of the cervix under 6 centimeters
- Written consent
Who cannot join
- - Not having a anesthesia consultation during the 48 hours before delivery
- With a contra-indication for an epidural
- To which an incident occurred during a previous epidural using a medication used in the study
- Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
- general anesthesia in the seven days preceding delivery
- Carry a pacemaker or heart grafted
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- Having Parkinson's disease history, insulin or non-insulin diabetes or chronic alcoholism
- Having cardiac arrhythmia (atrial fibrillation or frequent extrasystoles)
- Treated for hypertension by receptor antagonists of angiotensin type 2
- anti-arrhythmic treatment or blocker,
- Refusing to participate in the study
- With a contra-indication for the use of ropivacaine and sufentanil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.
Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).
Read more
The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.
There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).
- Conditions
- Labor, Obstetric, Pain
- Being tested
- Portable video pupillometer
- Keywords
- Labor, Obstetric, pain, pupil diameter, Visual Analogic Scale (VAS)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable video pupillometerDevice
Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Pain assess by :
* Visual Analogic Scale (VAS).
* Portable video pupillometer Receives: Device: Portable video pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameter variability
Compare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia. PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.
Measured: From baseline to fifteen minutes after start of Epidural regional anesthesia
Secondary outcomes (2)
pupil diameter
Compare the Pupil Diameter measured five seconds after time to peak of contraction before Epidural regional anesthesia and after Epidural regional anesthesia
Measured: From baseline to fifteen minutes after start of Epidural regional anesthesia
Visual Analogic Scale (VAS)
Compare the VAS measured at the end of contraction before Epidural regional anesthesia and after Epidural regional anesthesia.
Measured: From baseline to fifteen minutes after start of Epidural regional anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, ObstetricStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charier, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551354
- Sponsor's protocol ID
- 1208078
- Acronym
- PERIDANS
- Status last verified
- Sep 2015
- First submitted
- 11 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study
- ClinicalTrials.gov ID
- NCT02551354
- Acronym / sponsor ID
- PERIDANS / 1208078
- Conditions
- Labor, Obstetric, Pain
- Keywords
- Labor, Obstetric, pain, pupil diameter, Visual Analogic Scale (VAS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Sep 2015 (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.
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.
Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).
The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.
There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Portable video pupillometerPain assess by : * Visual Analogic Scale (VAS). * Portable video pupillometer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Obstetrical Labor
- Able to rate their pain using VAS
- dilatation of the cervix under 6 centimeters
- Written consent
Key exclusion criteria (12 listed)
- - Not having a anesthesia consultation during the 48 hours before delivery
- With a contra-indication for an epidural
- To which an incident occurred during a previous epidural using a medication used in the study
- Operated a unilateral or bilateral ocular surgery modifying the possibilities of variation of pupil diameter
- general anesthesia in the seven days preceding delivery
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 |
|---|---|---|
| Portable video pupillometerPortable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor | Device | Patients |
Primary outcome
Pupil diameter variability
Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia
Compare Pupil Diameter Variability (PDV) measured before Epidural regional anesthesia and after Epidural regional anesthesia. PDV is aera under the curve of Pupil Diameter from start of the contraction (baseline) to time to peak of the contraction.
2 secondary outcomes
pupil diameter
Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia
Visual Analogic Scale (VAS)
Time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia
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 16 Sep 2015.
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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.
David Charier, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable video pupillometer in people with Labor, Obstetric and Pain, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 12 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 16 Sep 2015. 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. 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?
Pupil diameter variability (time frame: From baseline to fifteen minutes after start of Epidural regional anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2015.