Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
NCT ID: NCT04919408
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
283 participants
INTERVENTIONAL
2021-07-12
2024-08-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients scheduled for cesarean section under spinal anesthesia
Patients scheduled for cesarean section under spinal anesthesia ASA I and II according to The ASA Physical Status Classification System
telephone survey
telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section
Interventions
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telephone survey
telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section
Eligibility Criteria
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Inclusion Criteria
* Patients ASA I and II according to The ASA Physical Status Classification System
Exclusion Criteria
* 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
18 Years
55 Years
FEMALE
No
Sponsors
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
OTHER
Responsible Party
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Principal Investigators
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Géraldine SLEHOFER-LHERIAU, MD
Role: STUDY_DIRECTOR
Anesthesiology department Hôpital Sainte Musse
Locations
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Hôpital Nord
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, , France
Countries
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References
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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.
Related Links
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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.
Other Identifiers
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2021-A00397-34
Identifier Type: OTHER
Identifier Source: secondary_id
2021-CHITS-003
Identifier Type: -
Identifier Source: org_study_id
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