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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
Intravenous perioperative Lidocain for pain Control and improvement of postoperative recovery
Placebo
Skåne University Hospital of Lund
Lund, Skåne County, Sweden
Opioid consumption at 24 hours
Sum of opioids consumed
Time frame: 24 hours postoperatively
Opioid consumption at 48 hours
Sum of opioids consumed
Time frame: 48 hours postoperatively
Opioid consumption at 72 hours
Sum of opioids consumed
Time frame: 72 hours postoperatively
Opioid consumption at 96 hours
Sum of opioids consumed
Time frame: 96 hours postoperatively
Opioid consumption at 120 hours
Sum of opioids consumed
Time frame: 120 hours postoperatively
Postoperative pain intensity
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
Number of participants with Postoperative comlications
Comparition of Complications classified according to Clavien Dindo, 0,1,2,3a,3b,4,5
Time frame: 30 days postoperatively
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 frame: 30 days postoperatively
Time to return of Bowel function
Time to first flatus and defacation
Time frame: Day 0-30 postoperatively
Number of participants with Postoperative nausea and vomiting
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Time frame: Day 1-5 postopertively
Level of Postoperative nausea and vomiting
Postoperative nausea and vomiting, as noted in questionary "Quality of recovery-40"
Time frame: Day 1-5 postopertively
Days in hospital
Length of hospital stay
Time frame: 0-90 days postoperatively
Level of MEGX concentrations
Concentration of the metabolite "MEGX" in patients blood
Time frame: Twice during surgery, and once 1 hour after surgery.
Level of Lidocaine concentration
Concentration of Lidocaine in patients blood
Time frame: Twice during surgery, and once 1 hour after surgery.
Mortality
death after surgery
Time frame: 30 days postoperatively
Rating of Quality of recovery-40
Quality of recovery questionary.
Time frame: Day 1-5 postoperatively
Number of participant with Adverse Events
All adverse events
Time frame: 0-30 days
Level of adverse events
All adverse events, classified according to CTCEA
Time frame: 0-30 days
Number of participants with Chronic Postsurgical pain
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Time frame: 3 months after surgery
Level of Chronic Postsurgical pain
Chronic Postsurgical pain, according to Brief Pain inventory- questionary
Time frame: 3 months after surgery
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