Post-partum Perineal PainPhase 4EPISIONCT02905695
Post-partum Perineal Pain - Chirocaine®
A Phase 4 study testing Chirocaine in people with Post-partum Perineal Pain and Episiotomy, run by Hopital Foch at 1 site in France.
Trial summary
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post-partum Perineal Pain, Episiotomy, Vaginal Tear
- What is being tested?
- Chirocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jul 2016
- Phase
- Phase 4
- 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
- Patients aged 18-45 years
- Single pregnancy.
- Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
- Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
- Patients affiliated to a national insurance scheme
- Patients who have given their written consent
Who cannot join
- Patient not speaking, reading, writing French.
- Multiple pregnancy.
- Breech delivery or instrumental delivery by forceps or spatula.
- Intact perineum.
- No epidural analgesia.
- Patient who represent contraindication to local anesthetics, severe arterial hypotension.
- Previous tear requiring sutures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.
- Conditions
- Post-partum Perineal Pain, Episiotomy, Vaginal Tear
- Being tested
- Chirocaine, Placebo
- Keywords
- Post-partum Perineal pain, Episiotomy, First-degree tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChirocaineDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Chirocaine Receives: Drug: Chirocaine |
| Group B | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-partum perineal pain measured by a numerical rating scale
Measured: 8 hours post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partum Perineal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Ayoubi, MD, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905695
- Sponsor's protocol ID
- 2010/44
- Acronym
- EPISIO
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear
- ClinicalTrials.gov ID
- NCT02905695
- Acronym / sponsor ID
- EPISIO / 2010/44
- Conditions
- Post-partum Perineal Pain, Episiotomy, Vaginal Tear
- Keywords
- Post-partum Perineal pain, Episiotomy, First-degree tear
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Sep 2016 (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.
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: ChirocaineChirocaine |
| Group B | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-45 years
- Single pregnancy.
- Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
- Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
- Patients affiliated to a national insurance scheme
Key exclusion criteria (7 listed)
- Patient not speaking, reading, writing French.
- Multiple pregnancy.
- Breech delivery or instrumental delivery by forceps or spatula.
- Intact perineum.
- No epidural analgesia.
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 |
|---|---|---|
| Chirocaine | Drug | Group A |
| Placebo | Other | Group B |
Primary outcome
Post-partum perineal pain measured by a numerical rating scale
Time frame: 8 hours post partum
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 19 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Jean-Marc Ayoubi, MD, PhD 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 Phase 4 study testing Chirocaine in people with Post-partum Perineal Pain and Episiotomy, 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 7 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 19 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-partum perineal pain measured by a numerical rating scale (time frame: 8 hours post partum). 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 19 Sep 2016.