Paracetamol Metabolism Research in Postoperative Hepatic Surgery (PARAFOI)

University Hospital, Lille

Status: Completed

Conditions: Paracetamol Causing Adverse Effects in Therapeutic Use; Hepatic Disease

Treatments: Drug: paracetamol; Procedure: hepatic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03297073

2015_61

2016-002632-32 (Other Identifier)

Details and patient eligibility

About

The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.

Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring surgery for hepatic resection by initiation under chest or laparoscopic without hepatocellular insufficiency,
• ASA score 1 to 3 (American Society of Anesthesiologists score ranging from 1 to 5 evaluating the preoperative health status of a patient),
• Verification of the understanding of the protocol,

Exclusion criteria

• Patients classified ASA 4 or 5,
• Allergy or intolerance to indocyanine green
• Allergy or intolerance to paracetamol,
• Taking of paracetamol the week before the intervention,
• Patient less than 60 Kgs (because decrease of doses of paracetamol),
• Emergency surgery, palliative surgery and surgical recovery,
• Psychic disorder,
• Contra-indication to a treatment used during the study,
• incapable major,
• Intellectual incapacity preventing proper understanding of the protocol,
• Pregnant or nursing woman,

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

major hepatic surgery

Experimental group

Description:

resection greater than or equal to three hepatic segments

Treatment:

Procedure: hepatic surgery

Drug: paracetamol

hepatic surgery

Experimental group

Description:

resection less than three hepatic segments

Treatment:

Procedure: hepatic surgery

Drug: paracetamol

hepatic surgery recovery

Experimental group

Treatment:

Procedure: hepatic surgery

Drug: paracetamol