Lidocaine in Liver Surgery

2023-508173-90-00 Phase II and Phase III (Integrated) Ended

Start 15 Nov 2021 · End 6 Dec 2025 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ended
Participants planned 124
Countries 1
Sites 1

Patients with liver tumours that have liver surgery performed

To evaluate the efficiency of intravenously administered Lidocaine in minor hepatectomy patients

Key facts

Sponsor
Region Skane
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration
15 Nov 2021 → 6 Dec 2025
Decision date (initial)
2024-09-30
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-508173-90-00
EudraCT number
2019-002361-35
ClinicalTrials.gov
NCT05153785

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Safety

To evaluate the efficiency of intravenously administered Lidocaine in
minor hepatectomy patients

Secondary objectives 1

  1. To evaluate lidocain's safety and effect on postoperative pain control and postoperative recovery in patients who undergo minor liver surgery

Conditions and MedDRA coding

Patients with liver tumours that have liver surgery performed

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Age ≥ 18 years.
  2. Patients planned for minor hepatectomy in Lund.
  3. Informed consent in writing.

Exclusion criteria 13

  1. ASA score >3
  2. Chirrosis
  3. Preoperative decreased liverfunction, defined as ASAT/ALAT/bilirubin above twice the upper normal limit
  4. Pregnancy
  5. AV- block >1 without pacemaker
  6. WHO class >2.
  7. Allergy to lidocaine or other local anaesthesia
  8. Heart failure
  9. Epilepsy
  10. Class 3 antiarythmis (such as cordarone)
  11. Ongoing treatment with opioids.
  12. Uncapable, unwilling or language difficulties making patient unable to understand scope of study
  13. concomittant drugs: Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, antiviral-HIV-medication and imidazol-drugs.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Total opioid consumption the first 24 hours. (mg morfin equivalents)

Secondary endpoints 14

  1. Total opioid consumption the first 48 hours. (mg morfin equivalents)
  2. Postoperative intensity of pain, NRS (numerical rating scale)
  3. Complications (Clavien-Dindo)
  4. Total Intravenous Opioid consumption in the first 24 hours, and after the first 48 hours (mg morfin equivalents)
  5. Total opioid consumption by day 3, 4, 5 (mg morfin equivalenter)
  6. Time to flatus
  7. Time to bowel movement
  8. Nausea
  9. vomiting
  10. Length of stay in hospital
  11. Mortality
  12. Lidocaine- and MEGX-koncentration in blood immediately after induction of anestesia , 30 minutes after resection and at the end of infusion.
  13. QoR-40
  14. adverse events

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Lidocaine

SUB08507MIG · Substance

Active substance
Lidocaine
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
1.5 mg/kg/h milligram(s)/kilogram/hour
Max total dose
1.5 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Sodium Chloride

SUB12581MIG · Substance

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
150 ml millilitre(s)
Max total dose
150 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Skane

32 Total trials 13 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Skane
Address
Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
City
Malmo
Postcode
211 74
Country
Sweden

Scientific contact point

Organisation
Region Skane
Contact name
Bobby Tingstedt

Public contact point

Organisation
Region Skane
Contact name
Bobby Tingstedt

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ended 124 1
Rest of world — 0 —

Investigational sites

Sweden

1 site · Ended
Lund University Hospital
Department of surgery, Getingevaegen 4, 222 42, Lund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2021-11-15 2025-12-06 2021-11-29 2025-06-12

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Lidokain_protokoll_1_1 1
Recruitment arrangements (for publication) Recruitment_arrangement_dummy 1
Subject information and informed consent form (for publication) Forskningspersoninformation 1
Synopsis of the protocol (for publication) synospis_lidokain240918 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-18 Sweden Acceptable with conditions
2024-09-30
 2024-09-30

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