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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02527577
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 2
• Duration (Months): 58.1
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer, Adult	Drug: RopivacaIne chlorhydrate; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. consumption of morphine over the first 48 hours postoperative. [at 48 hours postoperative]

Secondary Outcome Measures

1. pharmacokinetic of ropivacaine (plasma concentrations) [1, 2, 3, 6, 10, 24, 36, 48 hours post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de SAINT-ETIENNE	Saint-etienne		France	42000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: [e-mail] MOLLIEX, MD PhD, CHU de SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02527577
• Other Study ID Numbers: 0908127; 2009-017768-18; A100140-28
• First Posted: Aug 19, 2015
• Last Update Posted: Aug 19, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Carcinoma, Hepatocellular; Ropivacaine

Study Results

No Results Posted as of Aug 19, 2015