Perioperative Intravenous Lidocaine in Liver Surgery
- Conditions
- Liver MetastasesLiver CancerPostoperative PainOpioid Use
- Interventions
- Drug: Normal saline
- Registration Number
- NCT05153785
- Lead Sponsor
- Lund University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Age 18 yy
- Patient planned for minor hepatectomy
- Signed informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Normal saline The placebo arm will receive the same amount of normal Saline. Lidocaine arm Lidocaine 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.
- Primary Outcome Measures
Name Time Method Opioid consumption at 24 hours 24 hours postoperatively Sum of opioids consumed
- Secondary Outcome Measures
Name Time Method 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
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
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
Opioid consumption at 120 hours 120 hours postoperatively Sum of opioids consumed
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.
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
Trial Locations
- Locations (1)
Skåne University Hospital of Lund
🇸🇪Lund, Skåne, Sweden