Labor PainAPD-ANINCT01505283
Effect of Epidural Analgesia on the Parameter ANI During Childbirth
A study testing NaCl 0.9%, Sufentanil and lidocaine in people with Labor Pain, run by Hopital Foch at 1 site in France.
Trial summary
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- NaCl 0.9%, Sufentanil and lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Jul 2015
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Over 18 years,
- ASA I or II,
- No history of cardiovascular or respiratory disease
- No cardiovascular medication
- No treatment with a tocolytic agent(salbutamol, nicardipine)
- Desiring epidural analgesia at the early phase of labor pain
Who cannot join
- Too fast labour
- A pain score at or above 70 on the pain scale
- A disturbed EKG signal or extrasystoles
- Pace-Maker
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).
Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.
- Conditions
- Labor Pain
- Being tested
- NaCl 0.9%, Sufentanil, lidocaine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaCl 0.9%Drug
epidural administration of 6 ml of NaCl 0.9%
SufentanilDrug
epidural administration of sufentanil 10 µg
lidocaineDrug
epidural administration of lidocaine 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Group Saline | Placebo comparator | Epidural administration of saline Receives: Drug: NaCl 0.9% |
| Group Sufentanil | Experimental | Epidural administration of sufentanil Receives: Drug: Sufentanil |
| Group Lidocaine | Experimental | Epidural administration of lidocaine Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the ANI parameter with the VAS during labour
The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.
Measured: 2 hours
Secondary outcomes (2)
Effects of epidural sufentanil and of epidural local anesthetic on ANI
The secondary objective is to compare the effects of epidural sufentanil and a local anesthetic on the parameter ANI.
Measured: 2 hours
Effects of anxiety score on ANI
The secondary objective is to study the effects of anxiety on the parameter ANI.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hopital FochMorgan Le Guen, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505283
- Sponsor's protocol ID
- 2010/20
- Other IDs
- 2011-A00962-39
- Acronym
- APD-ANI
- Status last verified
- Nov 2016
- First submitted
- 4 Jan 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Analgesia on the Parameter ANI During Childbirth
- ClinicalTrials.gov ID
- NCT01505283
- Acronym / sponsor ID
- APD-ANI / 2010/20
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Jan 2012 (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.
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).
Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Saline | Placebo comparator | Drug: NaCl 0.9%Epidural administration of saline |
| Group Sufentanil | Experimental | Drug: SufentanilEpidural administration of sufentanil |
| Group Lidocaine | Experimental | Drug: lidocaineEpidural administration of lidocaine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Over 18 years,
- ASA I or II,
- No history of cardiovascular or respiratory disease
- No cardiovascular medication
- No treatment with a tocolytic agent(salbutamol, nicardipine)
Key exclusion criteria (5 listed)
- Too fast labour
- A pain score at or above 70 on the pain scale
- A disturbed EKG signal or extrasystoles
- Pace-Maker
- Diabetes mellitus
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 |
|---|---|---|
| NaCl 0.9%epidural administration of 6 ml of NaCl 0.9% | Drug | Group Saline |
| Sufentanilepidural administration of sufentanil 10 µg | Drug | Group Sufentanil |
| lidocaineepidural administration of lidocaine 50 mg | Drug | Group Lidocaine |
Primary outcome
Comparison of the ANI parameter with the VAS during labour
Time frame: 2 hours
The main objective of the research is to evaluate ANI as a measurment of pain caused by uterine contractions.
2 secondary outcomes
Effects of epidural sufentanil and of epidural local anesthetic on ANI
Time frame: 2 hours
Effects of anxiety score on ANI
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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.
Marc Fischler, MD study chair
Hopital Foch
Morgan Le Guen, 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 NaCl 0.9%, Sufentanil and lidocaine in people with Labor Pain, 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 6 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: stopped early, as of the sponsor's last update on 3 Nov 2016. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Comparison of the ANI parameter with the VAS during labour (time frame: 2 hours). 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 3 Nov 2016.