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

NCT04919408 | Completed

• 2 other identifiers: 2021-CHITS-0032021-A00397-34
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Post-cesarean Pain

Keywords

Chronic pain; Enhanced Rehabilitation After Surgery; Cesarean section; Persistant pain

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  6 months

• Specify the type and extent of the pain

  6 months

• Evaluate the chronical pain impact on daily activities of young mothers

  6 months

• Evaluate the rate of adherence to the ERAS protocol.

  24 months

Study Arms (1)

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

Other: telephone survey

Interventions

telephone survey OTHER

telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section

Patients scheduled for cesarean section under spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (2)

Hôpital Nord

Marseille, Bouches-du-Rhône, 13915, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Toulon, 83056, France

Location

Related Publications (1)

• 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.

  PMID: 14674981 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Géraldine SLEHOFER-LHERIAU, MD

  Anesthesiology department Hôpital Sainte Musse

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 9, 2021
• Study Start: July 12, 2021
• Primary Completion: April 17, 2024
• Study Completion: August 1, 2024
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)