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

NCT ID: NCT02527577

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ropivacaïne chlorhydrate monohydrate

Group Type EXPERIMENTAL

RopivacaIne chlorhydrate

Intervention Type DRUG

3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

injection Hour (H) 0, H12 ; H24, H36 ; H48

Interventions

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RopivacaIne chlorhydrate

3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48

Intervention Type DRUG

Placebo

injection Hour (H) 0, H12 ; H24, H36 ; H48

Intervention Type DRUG

Other Intervention Names

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3mg/kg NaCl 0,9%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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[email protected] MOLLIEX, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2009-017768-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A100140-28

Identifier Type: OTHER

Identifier Source: secondary_id

0908127

Identifier Type: -

Identifier Source: org_study_id

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