Inadequate Analgesia During Cesarean Section Under Spinal... | NCT07312487

Studies
Inadequate Analgesia During Cesarean Section Under Spinal Anesthesia

NCT07312487

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Dec 31, 2025Actual

Enrollment

2,450Estimated

Phase

Not provided

Conditions

Analgesia, Cesarean

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2024Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Dec 30, 2025

First Posted Date

Dec 31, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Dec 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Inadequate analgesia during cesarean section is a common condition, notably addressed by national recommendations from the SFAR (French Society of Anesthesia and Intensive Care) in 2021.

The objective of this study is to identify the specific characteristics of this condition in Strasbourg in terms of risk factors and management, and then to propose a protocol for its prevention and management.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,450Estimated

Measure	Description	Time Frame
General anesthesia rates		at day 1 post-operative

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult woman (age ≥18 years)
Giving birth by cesarean section between January 1, 2021, and December 31, 2022, at the Strasbourg University Hospital

Exclusion Criteria:

Patient who has expressed her opposition to the reuse of her data for scientific research purposes.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Adult woman (age ≥18 years) giving birth by cesarean section between January 1, 2021, and December 31, 2022, at the Strasbourg University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefanie KOESSLER, MD	Contact	33 3 88 12 70 90		stefanie.koessler@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésie Réanimation médecine Péri-Opératoire - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided