Clinical trial NCT05153785: 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
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Liver Metastases
Liver Cancer
Postoperative Pain
Opioid Use
Keywords: liver surgery
postoperative pain
Lidocaine
opioid use
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blinded placebo-controlled study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Opioid consumption at 24 hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Opioid consumption at 48 hours
timeFrame: 48 hours postoperatively
measure: Opioid consumption at 72 hours
timeFrame: 72 hours postoperatively
measure: Opioid consumption at 96 hours
timeFrame: 96 hours postoperatively
measure: Opioid consumption at 120 hours
timeFrame: 120 hours postoperatively
measure: Postoperative pain intensity
timeFrame: Day 0-5 postoperatively, twice every day
measure: Number of participants with Postoperative comlications
timeFrame: 30 days postoperatively
measure: Level of Postoperative comlications
timeFrame: 30 days postoperatively
measure: Time to return of Bowel function
timeFrame: Day 0-30 postoperatively
measure: Number of participants with Postoperative nausea and vomiting
timeFrame: Day 1-5 postopertively
measure: Level of Postoperative nausea and vomiting
timeFrame: Day 1-5 postopertively
measure: Days in hospital
timeFrame: 0-90 days postoperatively
measure: Level of MEGX concentrations
timeFrame: Twice during surgery, and once 1 hour after surgery.
measure: Level of Lidocaine concentration
timeFrame: Twice during surgery, and once 1 hour after surgery.
measure: Mortality
timeFrame: 30 days postoperatively
measure: Rating of Quality of recovery-40
timeFrame: Day 1-5 postoperatively
measure: Number of participant with Adverse Events
timeFrame: 0-30 days
measure: Level of adverse events
timeFrame: 0-30 days
measure: Number of participants with Chronic Postsurgical pain
timeFrame: 3 months after surgery
measure: Level of Chronic Postsurgical pain
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital of Lund
state: Skåne
Study officials:
affiliation: Lund University Hospital
name: Bobby Tingstedt, Prof
role: STUDY_DIRECTOR
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