Post-cesarean Pain Control Via Continuous Infusion of Rop... | NCT01211431

Studies
Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine

NCT01211431

Sponsor

Centre Hospitalier Universitaire de Nīmes

Status

Withdrawn

Last Update Posted

Jun 17, 2026Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Cesarean Section

Interventions

Reference
Experimental

Countries

Not provided

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

ID	Type	Description	Link
2008-004643-11	EudraCT Number

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No inclusions.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Oct 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Sep 28, 2010

First Submission Date that Met QC Criteria

Sep 28, 2010

First Posted Date

Sep 29, 2010Estimated

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

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Reference	Active Comparator	Intrathécale morphine is used for post-cesarean pain control	Drug: Reference
Experimental	Experimental	A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control	Drug: Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reference	Drug	Intrathécale morphine is used for post-cesarean pain control	Reference

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary VAS score	The patient is asked to evaluate cesarean-section related pain using a visual analog scale (VAS) score for pain on a scale of 1-10 in a sitting position.	36 hours post delivery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

single, normally progressing pregancy
term > 36 weeks amenorrhea
BMI between 20 and 25 kg/m^2 before pregnancy
height between 55 and 90 kg
cesarean section by Joel-Cohen or Pfannenstiel techniques
patient has signed consent
patient has social security coverage

Exclusion Criteria:

Multiple pregnancy
pathological pregnancy: hypertension (>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
term < 36 weeks amenorrhea
non-pregnancy related maternal pathology (insufficiency)
obesity (BMI > 25 kg/m^2 before pregnancy)
height < 155 cm or > 180 cm
weight < 55 kg or > 90 kg
patient refuses to sign consent
surgical technique other than Joel-Cohen or Pfannenstiel
hepatic insufficiency (prothrombin < 60%)
contra-indications for rachianesthesia: infection, hemostasis problems (platelets < 80.109/L, prothrombin < 60%, TCA > 40s)
allergy to local anesthestics
patient is participating in another study, or has participated in another study within the last 6 months
patient is under any type of guardianship

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Antoinie Guy Aya, MD	Centre Hospitalier Universitaire de Nīmes	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided