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

Centre Hospitalier Universitaire de Nīmes

Status and phase

Withdrawn

Phase 4

Conditions

Cesarean Section

Treatments

Drug: Experimental

Drug: Reference

Study type

Interventional

Funder types

Other

Identifiers

NCT01211431

2008-004643-11 (EudraCT Number)

AOI/2008/GA-01

Details and patient eligibility

About

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).

Sex

Female

Ages

18+ years old

Volunteers

No 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