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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151943
Recruitment Status : Terminated (The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.)
First Posted : June 29, 2010
Last Update Posted : November 3, 2016
Information provided by (Responsible Party):
Hopital Foch

June 24, 2010
June 29, 2010
November 3, 2016
October 2010
July 2012   (Final data collection date for primary outcome measure)
severity of postoperative pain [ Time Frame: 48 postoperative hours ]
Same as current
Complete list of historical versions of study NCT01151943 on Archive Site
  • delay before the first rescue dose of morphine [ Time Frame: 48 postoperative hours ]
  • morphine requirement [ Time Frame: 48 postoperative hours ]
  • complication of each loco-regional technique [ Time Frame: end of hospitalisation ]
  • patient's satisfaction [ Time Frame: end of hospitalisation ]
  • length of hospital stay [ Time Frame: end of hospitalisation ]
  • occurrence of a neuropathic postoperative pain [ Time Frame: 1 month postoperatively ]
Same as current
Not Provided
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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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloë PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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)
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2010-019662-88 ( EudraCT Number )
Not Provided
Not Provided
Hopital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler, MD Hôpital Foch
Hopital Foch
November 2016

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