Cesarean SectionPhase 4NCT01211431
Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine
A Phase 4 study testing Reference and Experimental in people with Cesarean Section, run by Centre Hospitalier Universitaire de Nīmes.
Trial summary
The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Reference and Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Oct 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single, normally progressing pregancy
- term > 36 weeks amenorrhea
- BMI between 20 and 25 kg/m^2 before pregnancy
- height between 55 and 90 kg
- cesarean section by Joel-Cohen or Pfannenstiel techniques
- patient has signed consent
- patient has social security coverage
Who cannot join
- Multiple pregnancy
- pathological pregnancy: hypertension (>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
- term < 36 weeks amenorrhea
- non-pregnancy related maternal pathology (insufficiency)
- obesity (BMI > 25 kg/m^2 before pregnancy)
- height < 155 cm or > 180 cm
Show all 14Show fewer
- weight < 55 kg or > 90 kg
- patient refuses to sign consent
- surgical technique other than Joel-Cohen or Pfannenstiel
- hepatic insufficiency (prothrombin < 60%)
- contra-indications for rachianesthesia: infection, hemostasis problems (platelets < 80.109/L, prothrombin < 60%, TCA > 40s)
- allergy to local anesthestics
- patient is participating in another study, or has participated in another study within the last 6 months
- patient is under any type of guardianship
About this study
Official title: Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain
The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).
- Conditions
- Cesarean Section
- Being tested
- Reference, Experimental
- Keywords
- cesarean section, pain, ropivacain, diclofena, morphine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReferenceDrug
Intrathécale morphine is used for post-cesarean pain control
ExperimentalDrug
A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
| Study group | Role | What they receive |
|---|---|---|
| Reference | Active comparator | Intrathécale morphine is used for post-cesarean pain control Receives: Drug: Reference |
| Experimental | Experimental | A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control Receives: Drug: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary VAS score
The patient is asked to evaluate cesarean-section related pain using a visual analog scale (VAS) score for pain on a scale of 1-10 in a sitting position.
Measured: 36 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Why it stopped: No inclusions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoinie Guy Aya, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211431
- Sponsor's protocol ID
- AOI/2008/GA-01
- Other IDs
- 2008-004643-11, 2008
- Status last verified
- Mar 2015
- First submitted
- 28 Sep 2010
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain
- ClinicalTrials.gov ID
- NCT01211431
- Acronym / sponsor ID
- AOI/2008/GA-01
- Conditions
- Cesarean Section
- Keywords
- cesarean section, pain, ropivacain, diclofena, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No inclusions.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Sep 2010 (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 goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference | Active comparator | Drug: ReferenceIntrathécale morphine is used for post-cesarean pain control |
| Experimental | Experimental | Drug: ExperimentalA solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- single, normally progressing pregancy
- term > 36 weeks amenorrhea
- BMI between 20 and 25 kg/m^2 before pregnancy
- height between 55 and 90 kg
- cesarean section by Joel-Cohen or Pfannenstiel techniques
Key exclusion criteria (14 listed)
- Multiple pregnancy
- pathological pregnancy: hypertension (>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
- term < 36 weeks amenorrhea
- non-pregnancy related maternal pathology (insufficiency)
- obesity (BMI > 25 kg/m^2 before pregnancy)
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 |
|---|---|---|
| ReferenceIntrathécale morphine is used for post-cesarean pain control | Drug | Reference |
| ExperimentalA solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control | Drug | Experimental |
Primary outcome
Primary VAS score
Time frame: 36 hours post delivery
The patient is asked to evaluate cesarean-section related pain using a visual analog scale (VAS) score for pain on a scale of 1-10 in a sitting position.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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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.
Antoinie Guy Aya, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reference and Experimental in people with Cesarean Section, run by Centre Hospitalier Universitaire de Nīmes.
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Primary VAS score (time frame: 36 hours post delivery). 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 17 Jun 2026.