idocain after liver surgery

Phase 1

• Conditions: Patients with liver tumours that have liver surgery performed; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2019-002361-35-SE
• Lead Sponsor: region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-16
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

-Age = 18 years.
-Patients planned for minor hepatectomy in Lund.
-Informed consent in writing.

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

-ASA score >3
-Chirrosis
-Preoperative decreased liverfunction, defined as ASAT/ALAT/bilirubin above twice the upper normal limit
-Pregnancy
-AV- block >1 without pacemaker
-WHO class >2.
-Allergy to lidocaine or other local anaesthesia
-Heart failure
-Epilepsy
-Class 3 antiarythmis (such as cordarone)
-Ongoing treatment with opioids.
-Uncapable, unwilling or language difficulties making patient unable to understand scope of study
-concomittant drugs: Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, antiviral-HIV-medication and imidazol-drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficiency of intravenously administered Lidocaine in minor hepatectomy patients ;Secondary Objective: To evaluate lidocain's safety and effect on postoperative pain control and postoperative recovery in patients who undergo minor liver surgery;Primary end point(s): Primary endpoints:-Total opioid consumption the first 24 hours. (mg morfin equivalents);Timepoint(s) of evaluation of this end point: After 24 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Total opioid consumption the first 48 hours. (mg morfin equivalents)<br>-Postoperative intensity of pain, NRS (numerical rating scale)<br>-Complications (Clavien-Dindo)<br>-Total Intravenous Opioid consumption in the first 24 hours, and after the first 48 hours (mg morfin equivalents)<br>-Total opioid consumption by day 3, 4, 5 (mg morfin equivalenter)<br>-Time to flatus <br>-Toe to bowel movement <br>-Nausea<br>-Vomiting<br>-Length of stay in hospital<br>-Mortality<br>-Lidocaine- and MEGX-koncentration in blood immediately after induction of anestesia , 30 minutes after resection and at the end of infusion. <br>-QoR-40<br>-adverse events<br>;Timepoint(s) of evaluation of this end point: Five Days postoperatively for endpoints related to surgery. Mortality will be evaluated after 90 Days. Adverse events will be monitored continously during the first 5 Days.