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

Liver Cancer, Adult Clinical Trial

— BLOC-TAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02527577
• Other study ID #: 0908127
• Secondary ID: 2009-017768-18A1
• Status: Terminated
• Phase: N/A
• First received: August 14, 2015
• Last updated: August 17, 2015
• Start date: April 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer, Adult

Intervention

Drug:
• RopivacaIne chlorhydrate
3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48
• Placebo
injection Hour (H) 0, H12 ; H24, H36 ; H48

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	consumption of morphine over the first 48 hours postoperative.		at 48 hours postoperative	No
Secondary	pharmacokinetic of ropivacaine (plasma concentrations)		1, 2, 3, 6, 10, 24, 36, 48 hours post-dose	No