Lidocain after liver surgery

Intavenous Lidocain and postoperative recovery after liver surgery- a randomized double blinded trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002361-35-SE

Enrollment

100

Registered

2019-12-16

Start date

2020-05-06

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Patients with liver tumours that have liver surgery performed

Interventions

Trade Name: Lidocaine Product Name: Lidocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: LIDOCAINE CAS Number: 73-78-9 Concentration unit: mg/ml milligram(s)/millilitre Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): -Total opioid consumption the first 48 hours. (mg morfin equivalents) -Postoperative intensity of pain, NRS (numerical rating scale) -Complications (Clavien-Dindo) -Total Intravenous Opioid consumption in the first 24 hours, and after the first 48 hours (mg morfin equivalents) -Total opioid consumption by day 3, 4, 5 (mg morfin equivalenter) -Time to flatus -Toe to bowel movement -Nausea -Vomiting -Length of stay in hospital -Mortality -Lidocaine- and MEGX-koncentration in blood immediately after induction of anestesia , 30 minutes after resection and at the end of infusion. -QoR-40 -adverse events ;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.	—

Measure

Time frame

Secondary end point(s): -Total opioid consumption the first 48 hours. (mg morfin equivalents) -Postoperative intensity of pain, NRS (numerical rating scale) -Complications (Clavien-Dindo) -Total Intravenous Opioid consumption in the first 24 hours, and after the first 48 hours (mg morfin equivalents) -Total opioid consumption by day 3, 4, 5 (mg morfin equivalenter) -Time to flatus -Toe to bowel movement -Nausea -Vomiting -Length of stay in hospital -Mortality -Lidocaine- and MEGX-koncentration in blood immediately after induction of anestesia , 30 minutes after resection and at the end of infusion. -QoR-40 -adverse events ;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.

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Countries

Sweden

Contacts

Public ContactBobby Tingstedt

Region Skåne

bobby.tingstedt@med.lu.se0046046171434

Outcome results

None listed

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