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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This study has been withdrawn prior to enrollment.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: March 22, 2013
Last verified: March 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Cesarean Section
 Drug: Reference
Drug: Experimental
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference
Intrathécale morphine is used for post-cesarean pain control
 Drug: Reference
Intrathécale morphine is used for post-cesarean pain control
Experimental: Experimental
A solution including both ropivacain and diclofenac continuously delivered to the wound 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211431

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Antoinie Guy Aya, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01211431     History of Changes
Other Study ID Numbers: AOI/2008/GA-01, 2008-004643-11
Study First Received: September 28, 2010
Last Updated: March 22, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
cesarean section
pain
ropivacain
diclofena
morphine

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013