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Paracetamol Metabolism Research in Postoperative Hepatic Surgery

NCT ID: NCT03297073

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-20

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Paracetamol Causing Adverse Effects in Therapeutic Use Hepatic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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major hepatic surgery

resection greater than or equal to three hepatic segments

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.

The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form

hepatic surgery

Intervention Type PROCEDURE

hepatic surgery

resection less than three hepatic segments

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.

The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form

hepatic surgery

Intervention Type PROCEDURE

hepatic surgery recovery

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.

The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form

hepatic surgery

Intervention Type PROCEDURE

Interventions

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paracetamol

Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.

The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form

Intervention Type DRUG

hepatic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Lebuffe, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Huriez, CHRU

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2016-002632-32

Identifier Type: OTHER

Identifier Source: secondary_id

2015_61

Identifier Type: -

Identifier Source: org_study_id