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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cesarean Section Other: Transversus Abdominis Plane (TAP) Block Other: Incisional Infiltration of Local Anesthetic Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
Study Start Date : October 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transversus Abdominis Plane (TAP) Block
Patients will receive a bilateral transversus abdominis plane block
Other: Transversus Abdominis Plane (TAP) Block
Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
Active Comparator: Incisional Infiltration of Local Anesthetic
Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
Other: Incisional Infiltration of Local Anesthetic
continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.

Primary Outcome Measures :
  1. severity of postoperative pain [ Time Frame: 48 postoperative hours ]

Secondary Outcome Measures :
  1. delay before the first rescue dose of morphine [ Time Frame: 48 postoperative hours ]
  2. morphine requirement [ Time Frame: 48 postoperative hours ]
  3. complication of each loco-regional technique [ Time Frame: end of hospitalisation ]
  4. patient's satisfaction [ Time Frame: end of hospitalisation ]
  5. length of hospital stay [ Time Frame: end of hospitalisation ]
  6. occurrence of a neuropathic postoperative pain [ Time Frame: 1 month postoperatively ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151943

Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hôpital Foch

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hopital Foch Identifier: NCT01151943     History of Changes
Other Study ID Numbers: 2010/15
2010-019662-88 ( EudraCT Number )
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Hopital Foch:
cesarean section
continuous wound infiltration
transversus abdominis plane block

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents