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

This study has been withdrawn prior to enrollment.
(No inclusions.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01211431
First received: September 28, 2010
Last updated: August 8, 2014
Last verified: August 2014

September 28, 2010
August 8, 2014
September 2010
October 2012   (final data collection date for primary outcome measure)
Primary VAS score [ Time Frame: 36 hours post delivery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01211431 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cesarean Section
  • Drug: Reference
    Intrathécale morphine is used for post-cesarean pain control
  • Drug: Experimental
    A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
  • Active Comparator: Reference
    Intrathécale morphine is used for post-cesarean pain control
    Intervention: Drug: Reference
  • Experimental: Experimental
    A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
    Intervention: Drug: Experimental
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01211431
AOI/2008/GA-01, 2008-004643-11
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Antoinie Guy Aya, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP