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Comparison of Two Types of Pain Relief After Cesarean Delivery (Cesar-Dol)

This study has been terminated.
(The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.)
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01151943
First received: June 24, 2010
Last updated: July 12, 2012
Last verified: July 2012
History of Changes

June 24, 2010
July 12, 2012
October 2010
July 2012   (final data collection date for primary outcome measure)
severity of postoperative pain [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01151943 on ClinicalTrials.gov Archive Site
  • delay before the first rescue dose of morphine [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]
  • morphine requirement [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]
  • complication of each loco-regional technique [ Time Frame: end of hospitalisation ] [ Designated as safety issue: No ]
  • patient's satisfaction [ Time Frame: end of hospitalisation ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: end of hospitalisation ] [ Designated as safety issue: No ]
  • occurrence of a neuropathic postoperative pain [ Time Frame: 1 month postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Types of Pain Relief After Cesarean Delivery
Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic

Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cesarean Section
  • Other: Transversus Abdominis Plane (TAP) Block
    Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
  • Other: Incisional Infiltration of Local Anesthetic
    continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.
  • Experimental: Transversus Abdominis Plane (TAP) Block
    Patients will receive a bilateral transversus abdominis plane block
    Intervention: Other: Transversus Abdominis Plane (TAP) Block
  • Active Comparator: Incisional Infiltration of Local Anesthetic
    Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
    Intervention: Other: Incisional Infiltration of Local Anesthetic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • scheduled cesarean section performed under spinal anesthesia
  • ASA I or II
  • height above 1,55 m
  • singleton pregnancy

Exclusion Criteria:

  • contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01151943
2010/15
No
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
July 2012

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