POSTOPERATIVE ANALGESIA USING PREPERITONEAL CONTINUOUS INFUSIONS OF ROPIVACAINE IN PATIENTS UNDERGOING LIVER SURGERY -CONSEQUENCES ON ROPIVACAINE METABOLISM - ROPI1

Conditions: PATIENTS WITH HEPATIC TUMORS BUT WITH A GOOD HEPATIC FUNCTION BEFORE SURGERY

Registration Number: EUCTR2009-013707-63-BE

Lead Sponsor: C.U.B ERASME HOSPITA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.PATIENTS BETWEEN 18 AN 80 YEARS OF AGE
2.ASA CLASSIFICATION 1-3
3.ELECTIVE HEPATIC SURGERY FOR HEPATIC TUMORS
4.THE EXTENT OF THE SURGERY SHOULD BE OF LESS THAN ONE HEPATIC ANATOMIC LOBE
5.SUBCOSTAL INCISION
6.NORMAL PREOPERATIVE HEPATIC FUNCTION

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.PREOPERATIVE COGNITIVE DYSFUNCTION OR PSYCHIATRIC DISORDER
2.PREOPERATIVE OPIOID OR NARCOTIC CONSUMPTION
3.HEPATIC CIRRHOSIS
4.ALL KINDS OF HEART BLOCKS
5.INDOCYANINE GREEN TEST AT 15 MINUTES OF MORE THEN 14%

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO ESTABLISH RATHER CONTINUOUS PREPERITONEAL INFUSION OF ROPIVACAINE IN PATIENTS UNDERGOING HEPATIC SURGERY BY SUBCOSTAL INCISION COULD BE A GOOD INDICATION AS AN ADJUVANT FOR POSTOPERATIVE ANALGESIA.;Secondary Objective: TO ESTABLISH IF THERE IS ANY CORRELATION BETWEEN THE DEGREE OF HEPATIC FUNCTION IMPAIRMENT AFTER HEPATIC SURGERY AND THE PLASMA CONCENTRATIONS OF ROPIVACAINE ADMINISTRATED VIA A WOUND CATHETER INFUSION.;Primary end point(s): ROPIACAINE IS MAINLY ELIMINATED BY HEPATIC METABOLISM .<br>WE EVALUATE THE RELATIONSHIP BETWEEN LIVER FUNCTION ASSESSED BY ICG_TEST AND ROPIVACAINE PLASMA CONCENTRATION ADMINISTRATED FOR ANALGESIA USING A WOUND CATHETER AFTEER HEPATIC SURGERY IN PATIENTS AITH HEPATIC TUMORS BUT GOOD PREOPERATIVE HEPATIC FUNCTION.

Secondary Outcome Measures