Perioperative Intravenous Lidocaine in Liver Surgery

Sponsor

Lund University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05153785

Collaborator

(none)

Enrollment

Location

Arms

49.5

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Metastases Liver Cancer Postoperative Pain Opioid Use	Drug: Lidocaine Drug: Normal saline	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized double blinded placebo-controlled studyRandomized double blinded placebo-controlled study

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine arm 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 Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery
Placebo Comparator: Placebo arm The placebo arm will receive the same amount of normal Saline.	Drug: Normal saline Placebo

Arm

Intervention/Treatment

Experimental: Lidocaine arm

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

Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery

Placebo Comparator: Placebo arm

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

Drug: Normal saline

Placebo

Outcome Measures

Primary Outcome Measures

Opioid consumption at 24 hours [24 hours postoperatively]
Sum of opioids consumed

Secondary Outcome Measures

Opioid consumption at 48 hours [48 hours postoperatively]
Sum of opioids consumed
Opioid consumption at 72 hours [72 hours postoperatively]
Sum of opioids consumed
Opioid consumption at 96 hours [96 hours postoperatively]
Sum of opioids consumed
Opioid consumption at 120 hours [120 hours postoperatively]
Sum of opioids consumed
Postoperative pain intensity [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
Number of participants with Postoperative comlications [30 days postoperatively]
Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5
Level of Postoperative comlications [30 days postoperatively]
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 [Day 0-30 postoperatively]
Time to first flatus and defacation
Number of participants with Postoperative nausea and vomiting [Day 1-5 postopertively]
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Level of Postoperative nausea and vomiting [Day 1-5 postopertively]
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Days in hospital [0-90 days postoperatively]
Length of hospital stay
Level of MEGX concentrations [Twice during surgery, and once 1 hour after surgery.]
Concentration of the metabolite "MEGX" in patients blood
Level of Lidocaine concentration [Twice during surgery, and once 1 hour after surgery.]
Concentration of Lidocaine in patients blood
Mortality [30 days postoperatively]
death after surgery
Rating of Quality of recovery-40 [Day 1-5 postoperatively]
Quality of recovery questionary.
Number of participant with Adverse Events [0-30 days]
All adverse events
Level of adverse events [0-30 days]
All adverse events, classified according to CTCEA
Number of participants with Chronic Postsurgical pain [3 months after surgery]
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Level of Chronic Postsurgical pain [3 months after surgery]
Chronic Postsurgical pain, according to Brief Pain inventory- questionary

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skåne University Hospital of Lund	Lund	Skåne	Sweden	22185

Sponsors and Collaborators

Lund University Hospital

Investigators

Study Director: Bobby Tingstedt, Prof, Lund University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Lund University Hospital

ClinicalTrials.gov Identifier:

NCT05153785

Other Study ID Numbers:

Lidokain vid leverkirurgi
2019-002361-35

First Posted:

Dec 10, 2021

Last Update Posted:

Dec 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lund University Hospital

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Study Results

No Results Posted as of Dec 10, 2021