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

November 2, 2016 updated by: Hopital Foch

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
severity of postoperative pain
Time Frame: 48 postoperative hours
48 postoperative hours

Secondary Outcome Measures

Outcome Measure
Time Frame
delay before the first rescue dose of morphine
Time Frame: 48 postoperative hours
48 postoperative hours
morphine requirement
Time Frame: 48 postoperative hours
48 postoperative hours
complication of each loco-regional technique
Time Frame: end of hospitalisation
end of hospitalisation
patient's satisfaction
Time Frame: end of hospitalisation
end of hospitalisation
length of hospital stay
Time Frame: end of hospitalisation
end of hospitalisation
occurrence of a neuropathic postoperative pain
Time Frame: 1 month postoperatively
1 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/15
  • 2010-019662-88 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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