Study Stopped
The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.
Comparison of Two Types of Pain Relief After Cesarean Delivery
Cesar-Dol
Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
2 other identifiers
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 3, 2016
November 1, 2016
1.8 years
June 24, 2010
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
severity of postoperative pain
48 postoperative hours
Secondary Outcomes (6)
delay before the first rescue dose of morphine
48 postoperative hours
morphine requirement
48 postoperative hours
complication of each loco-regional technique
end of hospitalisation
patient's satisfaction
end of hospitalisation
length of hospital stay
end of hospitalisation
- +1 more secondary outcomes
Study Arms (2)
Transversus Abdominis Plane (TAP) Block
EXPERIMENTALPatients will receive a bilateral transversus abdominis plane block
Incisional Infiltration of Local Anesthetic
ACTIVE COMPARATORPatients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours)
Interventions
Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.
Eligibility Criteria
You may qualify if:
- scheduled cesarean section performed under spinal anesthesia
- ASA I or II
- height above 1,55 m
- singleton pregnancy
You may not qualify if:
- contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hôpital Foch
Suresnes, 92150, France
Related Publications (1)
Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe 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.
PMID: 25093663DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2010
First Posted
June 29, 2010
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 3, 2016
Record last verified: 2016-11