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

NCT02527577 | Terminated

• 3 other identifiers: 09081272009-017768-18A100140-28
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer, Adult

Outcome Measures

Primary Outcomes (1)

• consumption of morphine over the first 48 hours postoperative.

  at 48 hours postoperative

Secondary Outcomes (1)

• pharmacokinetic of ropivacaine (plasma concentrations)

  1, 2, 3, 6, 10, 24, 36, 48 hours post-dose

Study Arms (2)

ropivacaïne chlorhydrate monohydrate

EXPERIMENTAL

Drug: RopivacaIne chlorhydrate

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

RopivacaIne chlorhydrate DRUG

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

Also known as: 3mg/kg

ropivacaïne chlorhydrate monohydrate

Placebo DRUG

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

Also known as: NaCl 0,9%

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hepatectomy or segmentectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• carine.labruyere@chu-st-etienne.fr MOLLIEX, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 19, 2015
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-07

Locations

FR (1)