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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01211431
• Other study ID #: AOI/2008/GA-01
• Secondary ID: 2008-004643-11
• Status: Withdrawn
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: March 24, 2015
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• Reference
Intrathécale morphine is used for post-cesarean pain control
• Experimental
A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No