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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
  Purpose

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 Intervention Phase
Cesarean Section
Other: Transversus Abdominis Plane (TAP) Block
Other: Incisional Infiltration of Local Anesthetic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • severity of postoperative pain [ Time Frame: 48 postoperative hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: October 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151943

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

No publications provided by Hopital Foch

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01151943     History of Changes
Other Study ID Numbers: 2010/15
Study First Received: June 24, 2010
Last Updated: July 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Levobupivacaine
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014