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Liver MetastasesPhase 2/3NCT05153785

Perioperative Intravenous Lidocaine in Liver Surgery

A Phase 2/3 study testing Lidocaine and Normal saline in people with Liver Metastases and Liver Cancer, run by Lund University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Metastases, Liver Cancer, Postoperative Pain
What is being tested?
Lidocaine and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteSweden
Study dates
15 Nov 2021to 6 Dec 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnancy
  • Cirrosis
  • ASA>3
  • Elevated liver enzymes
  • AV-block >1, without pacemaker
  • WHO class >2
Show all 12Show fewer
  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Skåne University Hospital of Lund

    Lund, Skåne County, 22185

Other trials in Sweden

About this study

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

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.

Read the detailed 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.

Being tested
Lidocaine, Normal saline
Keywords
liver surgery, postoperative pain, Lidocaine, opioid use
Medical subject headings
Liver Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery

  • Normal salineDrug

    Placebo

Study groups in NCT05153785
Study groupRoleWhat they receive
Lidocaine armExperimentalThe 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.
Receives: Drug: Lidocaine
Placebo armPlacebo comparatorThe placebo arm will receive the same amount of normal Saline.
Receives: Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption at 24 hours

    Sum of opioids consumed

    Measured: 24 hours postoperatively

Secondary outcomes (19)

  1. Opioid consumption at 48 hours

    Sum of opioids consumed

    Measured: 48 hours postoperatively

  2. Opioid consumption at 72 hours

    Sum of opioids consumed

    Measured: 72 hours postoperatively

  3. Opioid consumption at 96 hours

    Sum of opioids consumed

    Measured: 96 hours postoperatively

  4. Opioid consumption at 120 hours

    Sum of opioids consumed

    Measured: 120 hours postoperatively

  5. Postoperative pain intensity

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

    Measured: Day 0-5 postoperatively, twice every day

  6. Number of participants with Postoperative comlications

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

    Measured: 30 days postoperatively

  7. Level of Postoperative comlications

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

    Measured: 30 days postoperatively

  8. Time to return of Bowel function

    Time to first flatus and defacation

    Measured: Day 0-30 postoperatively

  9. Number of participants with Postoperative nausea and vomiting

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

    Measured: Day 1-5 postopertively

  10. Level of Postoperative nausea and vomiting

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

    Measured: Day 1-5 postopertively

  11. Days in hospital

    Length of hospital stay

    Measured: 0-90 days postoperatively

  12. Level of MEGX concentrations

    Concentration of the metabolite "MEGX" in patients blood

    Measured: Twice during surgery, and once 1 hour after surgery.

  13. Level of Lidocaine concentration

    Concentration of Lidocaine in patients blood

    Measured: Twice during surgery, and once 1 hour after surgery.

  14. Mortality

    death after surgery

    Measured: 30 days postoperatively

  15. Rating of Quality of recovery-40

    Quality of recovery questionary.

    Measured: Day 1-5 postoperatively

  16. Number of participant with Adverse Events

    All adverse events

    Measured: 0-30 days

  17. Level of adverse events

    All adverse events, classified according to CTCEA

    Measured: 0-30 days

  18. Number of participants with Chronic Postsurgical pain

    Chronic Postsurgical pain, according to Brief Pain inventory- questionary

    Measured: 3 months after surgery

  19. Level of Chronic Postsurgical pain

    Chronic Postsurgical pain, according to Brief Pain inventory- questionary

    Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start15 Nov 2021
  3. Primary completion12 Jun 2025
  4. Study completion6 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized double blinded placebo-controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153785
Sponsor's protocol ID
Lidokain vid leverkirurgi
Other IDs
2019-002361-35, 2019
Status last verified
Dec 2025
First submitted
12 Nov 2021
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.

    PubMed 23044681

  • Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.

    PubMed 18844267

  • Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

    PubMed 21061107

  • McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

    PubMed 20518581

  • Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.

    PubMed 29864216

  • Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.

    PubMed 26184397

  • Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.

    PubMed 28114177

  • Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.

    PubMed 19843784

  • Ortiz MP, Godoy MC, Schlosser RS, Ortiz RP, Godoy JP, Santiago ES, Rigo FK, Beck V, Duarte T, Duarte MM, Menezes MS. Effect of endovenous lidocaine on analgesia and serum cytokines: double-blinded and randomized trial. J Clin Anesth. 2016 Dec;35:70-77. doi: 10.1016/j.jclinane.2016.07.021. Epub 2016 Aug 6.

    PubMed 27871598

  • Sridhar P, Sistla SC, Ali SM, Karthikeyan VS, Badhe AS, Ananthanarayanan PH. Effect of intravenous lignocaine on perioperative stress response and post-surgical ileus in elective open abdominal surgeries: a double-blind randomized controlled trial. ANZ J Surg. 2015 Jun;85(6):425-9. doi: 10.1111/ans.12783. Epub 2014 Jul 31.

    PubMed 25078385

  • Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.

    PubMed 16952918

  • Moore PA, Hersh EV. Local anesthetics: pharmacology and toxicity. Dent Clin North Am. 2010 Oct;54(4):587-99. doi: 10.1016/j.cden.2010.06.015.

    PubMed 20831923

  • Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.

    PubMed 15635516

  • Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.

    PubMed 3898920

  • Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.

    PubMed 15041597

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Lidocaine and Normal saline in people with Liver Metastases and Liver Cancer, run by Lund University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption at 24 hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05153785, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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