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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013707-63-BE

Enrollment

Registered

2010-03-04

Start date

2010-03-05

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: NAROPIN 2mg/ml Product Name: NAROPIN 2mg/ml Pharmaceutical Form: Solution for injection CAS Number: 132112357 Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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%

Design outcomes

Primary

Measure	Time frame
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 . 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.	—

Measure

Time frame

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 . 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.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026