Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection. (BLOC-TAP)

August 17, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection

The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.

So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.

Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.

This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

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
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hepatectomy or segmentectomy

Exclusion Criteria:

  • Sepsis uncontrolled current
  • Overdose in anticoagulant during general anesthesia
  • Thrombocytopenia <50 g / dl
  • Severe renal impairment: Cockcroft <30 ml / min
  • history of ventricular arrhythmia serious unexplained .*
  • Allergy to local anesthetics of the amide
  • Contraindication to remifentanil and morphine
  • Hypovolemia

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
injection Hour (H) 0, H12 ; H24, H36 ; H48
Other Names:
  • NaCl 0,9%
Experimental: ropivacaïne chlorhydrate monohydrate
Drug: RopivacaIne chlorhydrate
3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48
Other Names:
  • 3mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
consumption of morphine over the first 48 hours postoperative.
Time Frame: at 48 hours postoperative
at 48 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
pharmacokinetic of ropivacaine (plasma concentrations)
Time Frame: 1, 2, 3, 6, 10, 24, 36, 48 hours post-dose
1, 2, 3, 6, 10, 24, 36, 48 hours post-dose

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD, CHU de Saint-Etienne

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

April 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908127
  • 2009-017768-18 (EudraCT Number)
  • A100140-28 (Other Identifier: AFSSAPS)

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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