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

Primary Purpose

Liver Cancer, Adult

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RopivacaIne chlorhydrate
Placebo
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer, Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ropivacaïne chlorhydrate monohydrate

placebo

Arm Description

Outcomes

Primary Outcome Measures

consumption of morphine over the first 48 hours postoperative.

Secondary Outcome Measures

pharmacokinetic of ropivacaine (plasma concentrations)

Full Information

First Posted
August 14, 2015
Last Updated
August 17, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02527577
Brief Title
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection.
Acronym
BLOC-TAP
Official Title
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
difficulties to recruit patients
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ropivacaïne chlorhydrate monohydrate
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RopivacaIne chlorhydrate
Other Intervention Name(s)
3mg/kg
Intervention Description
3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0,9%
Intervention Description
injection Hour (H) 0, H12 ; H24, H36 ; H48
Primary Outcome Measure Information:
Title
consumption of morphine over the first 48 hours postoperative.
Time Frame
at 48 hours postoperative
Secondary Outcome Measure Information:
Title
pharmacokinetic of ropivacaine (plasma concentrations)
Time Frame
1, 2, 3, 6, 10, 24, 36, 48 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

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

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