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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Reference
* Drug: Experimental


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference<br>Intrathécale morphine is used for post-cesarean pain control | Drug: Reference<br>* Intrathécale morphine is used for post-cesarean pain control<br>|
| Experimental: Experimental<br>A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control | Drug: Experimental<br>* A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, pain, ropivacain, diclofena, morphine