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Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol. (ChroCéRAAC)

I

Intermunicipal Hospital Center Toulon

Status

Completed

Conditions

Chronic Post-cesarean Pain

Treatments

Other: telephone survey

Study type

Interventional

Funder types

Other

Identifiers

NCT04919408
2021-A00397-34 (Other Identifier)
2021-CHITS-003

Details and patient eligibility

About

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.

Full 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.

Enrollment

283 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled for cesarean section under spinal anesthesia
  • Patients ASA I and II according to The ASA Physical Status Classification System

Exclusion criteria

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 design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

283 participants in 1 patient group

Patients scheduled for cesarean section under spinal anesthesia
Experimental group
Description:
Patients scheduled for cesarean section under spinal anesthesia ASA I and II according to The ASA Physical Status Classification System
Treatment:
Other: telephone survey

Trial contacts and locations

2

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Central trial contact

Sophie Lafond

Data sourced from clinicaltrials.gov

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