Perioperative Intravenous Lidocaine in Liver Surgery

Lund University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain; Liver Metastases; Opioid Use; Liver Cancer

Treatments: Drug: Normal saline; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05153785

2019-002361-35 (EudraCT Number)

Lidokain vid leverkirurgi

Details and patient eligibility

About

This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.

Full description

Patientes will be randozied in blocks of eight.

The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 Days.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 yy
• Patient planned for minor hepatectomy
• Signed informed consent

Exclusion criteria

• Pregnancy
• Cirrosis
• ASA>3
• Elevated liver enzymes
• AV-block >1, without pacemaker
• WHO class >2
• Allergy against Lidocain or other amid-type local anasthesia
• Heart failure
• Epilepsy
• Treatment with class III anti-arythimic medication
• Preoperative ongoing opioid usage
• Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

Lidocaine arm

Experimental group

Description:

The experimental arm will receive a bolus of 1,5mg/kg Lidocaine before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery.

Treatment:

Drug: Lidocaine

Placebo arm

Placebo Comparator group

Description:

The placebo arm will receive the same amount of normal Saline.

Treatment:

Drug: Normal saline