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

Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211431

Enrollment

Registered

2010-09-29

Start date

2010-09-01

Completion date

2012-10-01

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

cesarean section, pain, ropivacain, diclofena, morphine

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).

Interventions

DRUGReference

Intrathécale morphine is used for post-cesarean pain control

DRUGExperimental

A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Primary VAS score	36 hours post delivery	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.

Contacts

PRINCIPAL_INVESTIGATORAntoinie Guy Aya, MD

Centre Hospitalier Universitaire de Nīmes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026