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Completed

NCT Number: NCT05153785

Perioperative Intravenous Lidocaine in Liver Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Skåne University Hospital of Lund

Lund, Skåne County, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine

Drug

Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery

normal saline

Drug

Placebo

Primary outcomes

  1. Opioid consumption at 24 hours

    Time frame: 24 hours postoperatively

    Sum of opioids consumed

Secondary outcomes

  1. Opioid consumption at 48 hours

    Time frame: 48 hours postoperatively

    Sum of opioids consumed

  2. Opioid consumption at 72 hours

    Time frame: 72 hours postoperatively

    Sum of opioids consumed

  3. Opioid consumption at 96 hours

    Time frame: 96 hours postoperatively

    Sum of opioids consumed

  4. Opioid consumption at 120 hours

    Time frame: 120 hours postoperatively

    Sum of opioids consumed

  5. Postoperative pain intensity

    Time frame: Day 0-5 postoperatively, twice every day

    Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain

  6. Number of participants with Postoperative comlications

    Time frame: 30 days postoperatively

    Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5

  7. Level of Postoperative comlications

    Time frame: 30 days postoperatively

    Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death.

  8. Time to return of Bowel function

    Time frame: Day 0-30 postoperatively

    Time to first flatus and defacation

  9. Number of participants with Postoperative nausea and vomiting

    Time frame: Day 1-5 postopertively

    Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"

  10. Level of Postoperative nausea and vomiting

    Time frame: Day 1-5 postopertively

    Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"

  11. Days in hospital

    Time frame: 0-90 days postoperatively

    Length of hospital stay

  12. Level of MEGX concentrations

    Time frame: Twice during surgery, and once 1 hour after surgery.

    Concentration of the metabolite "MEGX" in patients blood

  13. Level of Lidocaine concentration

    Time frame: Twice during surgery, and once 1 hour after surgery.

    Concentration of Lidocaine in patients blood

  14. Mortality

    Time frame: 30 days postoperatively

    death after surgery

  15. Rating of Quality of recovery-40

    Time frame: Day 1-5 postoperatively

    Quality of recovery questionary.

  16. Number of participant with Adverse Events

    Time frame: 0-30 days

    All adverse events

  17. Level of adverse events

    Time frame: 0-30 days

    All adverse events, classified according to CTCEA

  18. Number of participants with Chronic Postsurgical pain

    Time frame: 3 months after surgery

    Chronic Postsurgical pain, according to Brief Pain inventory- questionary

  19. Level of Chronic Postsurgical pain

    Time frame: 3 months after surgery

    Chronic Postsurgical pain, according to Brief Pain inventory- questionary

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

Intravenous Lidocaine for Postoperative Recovery in Liver Surgery, a Randomized Double Blinded Placebo-controlled Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2021
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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