Clinical trial NCT04919408: Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
Official title: Evaluation of the Incidence of Chronic Post-cesarean Pain as Part of an Enhanced Recovery After Surgery (ERAS) Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post-cesarean Pain
Keywords: Chronic pain
Enhanced Rehabilitation After Surgery
Cesarean section
Persistant pain
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 283
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
timeFrame: 3 months
Secondary outcomes:
measure: To study the incidence of chronic post-surgical pain in scheduled cesarean section under spinal anesthesia as part of a ERAS protocol.
timeFrame: 6 months
measure: Specify the type and extent of the pain
timeFrame: 6 months
measure: Evaluate the chronical pain impact on daily activities of young mothers
timeFrame: 6 months
measure: Evaluate the rate of adherence to the ERAS protocol.
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Nord
state: Bouches-du-Rhône
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Study officials:
affiliation: Anesthesiology department Hôpital Sainte Musse
name: Géraldine SLEHOFER-LHERIAU, MD
role: STUDY_DIRECTOR
References:
citation: 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.