Perioperative Intravenous Lidocaine in Liver Surgery

NCT05153785 | Completed Phase 2 DMC

• 2 other identifiers: Lidokain vid leverkirurgi2019-002361-35
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Metastases; Liver Cancer; Postoperative Pain; Opioid Use

Keywords

liver surgery; postoperative pain; Lidocaine; opioid use

Outcome Measures

Primary Outcomes (1)

• Opioid consumption at 24 hours

  Sum of opioids consumed

  24 hours postoperatively

Secondary Outcomes (19)

• Opioid consumption at 48 hours

  48 hours postoperatively

• Opioid consumption at 72 hours

  72 hours postoperatively

• Opioid consumption at 96 hours

  96 hours postoperatively

• Opioid consumption at 120 hours

  120 hours postoperatively

• Postoperative pain intensity

  Day 0-5 postoperatively, twice every day

Study Arms (2)

Lidocaine arm

EXPERIMENTAL

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.

Drug: Lidocaine

Placebo arm

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Lidocaine DRUG

Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery

Lidocaine arm

Normal saline DRUG

Placebo

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Skåne University Hospital of Lund

Lund, Skåne County, 22185, Sweden

Location

Related Publications (29)

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MeSH Terms

Conditions

Liver Neoplasms; Pain, Postoperative

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bobby Tingstedt, Prof

  Lund University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blinded placebo-controlled study

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 10, 2021
• Study Start: November 15, 2021
• Primary Completion: June 12, 2025
• Study Completion: December 6, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication, for 10 years.

Locations

SE (1)