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Perioperative Intravenous Lidocaine in Liver Surgery

Primary Purpose

Liver Metastases, Liver Cancer, Postoperative Pain

Status
Recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases focused on measuring liver surgery, postoperative pain, Lidocaine, opioid use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Skåne University Hospital of LundRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine arm

Placebo arm

Arm 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.

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

Outcomes

Primary Outcome Measures

Opioid consumption at 24 hours
Sum of opioids consumed

Secondary Outcome Measures

Opioid consumption at 48 hours
Sum of opioids consumed
Opioid consumption at 72 hours
Sum of opioids consumed
Opioid consumption at 96 hours
Sum of opioids consumed
Opioid consumption at 120 hours
Sum of opioids consumed
Postoperative pain intensity
Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain
Number of participants with Postoperative comlications
Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5
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.
Time to return of Bowel function
Time to first flatus and defacation
Number of participants with Postoperative nausea and vomiting
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Level of Postoperative nausea and vomiting
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Days in hospital
Length of hospital stay
Level of MEGX concentrations
Concentration of the metabolite "MEGX" in patients blood
Level of Lidocaine concentration
Concentration of Lidocaine in patients blood
Mortality
death after surgery
Rating of Quality of recovery-40
Quality of recovery questionary.
Number of participant with Adverse Events
All adverse events
Level of adverse events
All adverse events, classified according to CTCEA
Number of participants with Chronic Postsurgical pain
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Level of Chronic Postsurgical pain
Chronic Postsurgical pain, according to Brief Pain inventory- questionary

Full Information

First Posted
November 12, 2021
Last Updated
November 29, 2021
Sponsor
Lund University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05153785
Brief Title
Perioperative Intravenous Lidocaine in Liver Surgery
Official Title
Intravenous Lidocaine for Postoperative Recovery in Liver Surgery, a Randomized Double Blinded Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases, Liver Cancer, Postoperative Pain, Opioid Use
Keywords
liver surgery, postoperative pain, Lidocaine, opioid use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded placebo-controlled study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine arm
Arm Type
Experimental
Arm 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.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
The placebo arm will receive the same amount of normal Saline.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Opioid consumption at 24 hours
Description
Sum of opioids consumed
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Opioid consumption at 48 hours
Description
Sum of opioids consumed
Time Frame
48 hours postoperatively
Title
Opioid consumption at 72 hours
Description
Sum of opioids consumed
Time Frame
72 hours postoperatively
Title
Opioid consumption at 96 hours
Description
Sum of opioids consumed
Time Frame
96 hours postoperatively
Title
Opioid consumption at 120 hours
Description
Sum of opioids consumed
Time Frame
120 hours postoperatively
Title
Postoperative pain intensity
Description
Numerical rating scale (NRS) in rest and activity, scale 0-10, 0=no pain, 10=worst imaginable pain
Time Frame
Day 0-5 postoperatively, twice every day
Title
Number of participants with Postoperative comlications
Description
Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5
Time Frame
30 days postoperatively
Title
Level of Postoperative comlications
Description
Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4a,4b,5, 0 beeing none and 5 beeng death.
Time Frame
30 days postoperatively
Title
Time to return of Bowel function
Description
Time to first flatus and defacation
Time Frame
Day 0-30 postoperatively
Title
Number of participants with Postoperative nausea and vomiting
Description
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Time Frame
Day 1-5 postopertively
Title
Level of Postoperative nausea and vomiting
Description
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Time Frame
Day 1-5 postopertively
Title
Days in hospital
Description
Length of hospital stay
Time Frame
0-90 days postoperatively
Title
Level of MEGX concentrations
Description
Concentration of the metabolite "MEGX" in patients blood
Time Frame
Twice during surgery, and once 1 hour after surgery.
Title
Level of Lidocaine concentration
Description
Concentration of Lidocaine in patients blood
Time Frame
Twice during surgery, and once 1 hour after surgery.
Title
Mortality
Description
death after surgery
Time Frame
30 days postoperatively
Title
Rating of Quality of recovery-40
Description
Quality of recovery questionary.
Time Frame
Day 1-5 postoperatively
Title
Number of participant with Adverse Events
Description
All adverse events
Time Frame
0-30 days
Title
Level of adverse events
Description
All adverse events, classified according to CTCEA
Time Frame
0-30 days
Title
Number of participants with Chronic Postsurgical pain
Description
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Time Frame
3 months after surgery
Title
Level of Chronic Postsurgical pain
Description
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Östrand, MD
Phone
+46-(0)46-171000
Email
emil.ostrand@skane.se
First Name & Middle Initial & Last Name or Official Title & Degree
Bobby Tingstedt, Prof
Phone
+46-(0)46-171000
Email
bobby.tingstedt@skane.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobby Tingstedt, Prof
Organizational Affiliation
Lund University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Skåne University Hospital of Lund
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Östrand, MD
Phone
+46-46-171000
Email
emil.ostrand@med.lu.se

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After publication, for 10 years.
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Perioperative Intravenous Lidocaine in Liver Surgery

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