Overview

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

Status:
Withdrawn
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de NÄ«mes
Treatments:
Morphine
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