Chronic Post-cesarean PainChroCéRAACNCT04919408
Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
A study testing telephone survey in people with Chronic Post-cesarean Pain, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites in France.
Trial summary
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Chronic Post-cesarean Pain
- What is being tested?
- telephone survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jul 2021to 1 Aug 2024
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for cesarean section under spinal anesthesia
- Patients ASA I and II according to The ASA Physical Status Classification System
Who cannot join
- intervention under general anesthesia
- complication during the operation
- post-partum haemorrrhage
- pre-op anemia <9g / dl
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice.
- Patient unable to answer the questionnaires by telephone (not speaking French, hard of hearing, mute French language, hearing impaired, mute...)
- Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Nord
Marseille, Bouches-du-Rhône, 13915
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, 83056
About this study
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.
The ERAS has been scientifically validated and standardized in many surgical disciplines since the implementation of guidelines in France in 2016.
Read more
Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.
Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.
But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.
Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.
It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.
Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.
In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.
To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.
This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.
Read the detailed description
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.
The ERAS has been scientifically validated and is currently standardized in many surgical disciplines since the implementation of guidelines in France in 2016.
Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.
Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.
But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.
Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.
It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.
Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.
In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.
To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.
This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.
- Conditions
- Chronic Post-cesarean Pain
- Being tested
- telephone survey
- Keywords
- Chronic pain, Enhanced Rehabilitation After Surgery, Cesarean section, Persistant pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone surveyOther
telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for cesarean section under spinal anesthesia | Experimental | Patients scheduled for cesarean section under spinal anesthesia ASA I and II according to The ASA Physical Status Classification System Receives: Other: telephone survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
The importance of the pain will be assessed using a verbal scale made up of the items : absent, minimal, moderate and severe.
The incidence rate at 3 months will be calculated as follows:
Number of patients with minimal, moderate or severe scar pain 3 months after their cesarean section / Number of patients evaluable at 3 months
Measured: 3 months
Secondary outcomes (4)
To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
The importance of the pain will be assessed using a verbal scale made up of the items : absent, minimal, moderate and severe.
The incidence rate at 6 months will be calculated as follows:
Number of patients with minimal, moderate or severe scar pain 6 months after their cesarean section / Number of patients evaluable at 6 months
Measured: 6 months
Specify the type and extent of the pain
The type and extent of the pain will be assessed using a verbal scale adapted from the questionnaire used in the study by L. Nikolajsen et al(1), and the DN4 questionnaire to search for neuropathic pain.
Measured: 6 months
Evaluate the chronical pain impact on daily activities of young mothers
The chronical pain impact on daily activities of young mothers will be assessed using a verbal scale adapted from the questionnaire used in the study by L. Nikolajsen et al(1)
Measured: 6 months
Evaluate the rate of adherence to the ERAS protocol.
As the anesthesiology department is affiliated with the French ERAS society : GRACE (French-speaking group for improved rehabilitation after surgery), we will use their audit tool to assess the rate of adherence to ERAS protocol.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start12 Jul 2021
- Primary completion17 Apr 2024
- Study completion1 Aug 2024
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 Chronic Post-cesarean 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine SLEHOFER-LHERIAU, MD, Study director, Anesthesiology department Hôpital Sainte Musse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919408
- Sponsor's protocol ID
- 2021-CHITS-003
- Other IDs
- 2021-A00397-34
- Acronym
- ChroCéRAAC
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.
PubMed 14674981
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
- ClinicalTrials.gov ID
- NCT04919408
- Acronym / sponsor ID
- ChroCéRAAC / 2021-CHITS-003
- Conditions
- Chronic Post-cesarean Pain
- Keywords
- Chronic pain, Enhanced Rehabilitation After Surgery, Cesarean section, Persistant pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Jun 2021 (actual)
- 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.
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.
The ERAS has been scientifically validated and standardized in many surgical disciplines since the implementation of guidelines in France in 2016.
Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.
Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.
But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.
Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.
It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.
Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.
In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.
To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.
This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.
Detailed description
Enhanced Rehabilitation After Surgery (ERAS), developed in the 1990s, is a program encompassing a set of measures before, during and after surgery aimed at improving management by promoting the early recovery of the patient's abilities after surgery.
The ERAS has been scientifically validated and is currently standardized in many surgical disciplines since the implementation of guidelines in France in 2016.
Regarding the obstetrical field, it was not until 2018 that the caesarean section could benefit from ERAS, with the publication of specific guidelines.
Several studies have been able to demonstrate ERAS effectiveness in reducing the length of hospitalization, postoperative complications, the consumption of analgesics immediately after surgery, and the financial cost, including in the context of cesarean sections.
But beyond immediate benefit, the impact of an ERAS protocol on chronic pain has not yet been evaluated.
Chronic pain is defined as physical discomfort that persists for more than 2 months after surgery.
It was not until 2004 that research focused on chronic post-cesarean pain, finding an incidence of chronic pain of 18.6% at 3 months and 12.3% at 6 months. In 2016, another study estimated an incidence of chronic pain in the caesarean scar at 15% at 3 months and 11% at 1 year. The investigators can notice that the presence of chronic post-cesarean pain remained stable over this period.
Several risk factors have been identified, such as the presence of acute pain immediately after surgery, the type of anesthesia, the type of surgical incision or a significant state of anxiety before the operation.
In this context, the investigators wish to assess the rate of chronic post-surgical pain in scheduled cesarean sections (excluding emergencies) under spinal anesthesia as part of a ERAS protocol. The investigatrors will also specify the type of pain and its impact on the daily activities of young mothers and will assess the level of adherence of medical and paramedical teams to the ERAS protocol.
To answer these questions, the investigators will conduct a telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section. The pain studied is defined as being the pain at the level of the caesarean scar.
This is an innovative subject evaluating the impact of the implementation of an ERAS protocol on chronic pain. Depending on the results, the investigators will be able to optimize the prevention of chronic pain of cesarean section.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for cesarean section under spinal anesthesia | Experimental | Other: telephone surveyPatients scheduled for cesarean section under spinal anesthesia ASA I and II according to The ASA Physical Status Classification System |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients scheduled for cesarean section under spinal anesthesia
- Patients ASA I and II according to The ASA Physical Status Classification System
Key exclusion criteria (7 listed)
- intervention under general anesthesia
- complication during the operation
- post-partum haemorrrhage
- pre-op anemia <9g / dl
- Patient under judicial protection (guardianship, curatorship...) or safeguard of justice.
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 |
|---|---|---|
| telephone surveytelephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section | Other | Patients scheduled for cesarean section under spinal anesthesia |
Primary outcome
To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
Time frame: 3 months
The importance of the pain will be assessed using a verbal scale made up of the items : absent, minimal, moderate and severe. The incidence rate at 3 months will be calculated as follows: Number of patients with minimal, moderate or severe scar pain 3 months after their cesarean section / Number of patients evaluable at 3 months
4 secondary outcomes
To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
Time frame: 6 months
Specify the type and extent of the pain
Time frame: 6 months
Evaluate the chronical pain impact on daily activities of young mothers
Time frame: 6 months
Evaluate the rate of adherence to the ERAS protocol.
Time frame: 24 months
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 7 Jul 2026.
- Background: PubMed 14674981Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.
- As the anesthesia service is affiliated with the French ERAS Society GRACE (French-speaking group for improved rehabilitation after surgery), we will use their audit tool to assess the rate of adherence to ERAS protocol for cesarean section.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Post-cesarean Pain
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Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
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Postoperative Pain, Cesarean Section Surgery
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.
Géraldine SLEHOFER-LHERIAU, MD study director
Anesthesiology department Hôpital Sainte Musse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone survey in people with Chronic Post-cesarean Pain, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 2 sites 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 2 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol. (time frame: 3 months). 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 NCT04919408, 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 7 Jul 2026.