Postoperative pain after colon rectal cancer surgery are mainly intended to relieve as well resting as activity-induced pain. Secondarily, the choice of pain management should take into consideration how to ensure the earliest possible mobilization and rapid fluid and food intake. There are now some evidence in laparoscopic gastrointestinal surgery that supports that perioperative infusion of lidocaine intravenously can reduce opioid consumption and length of postoperative ileus. MedDRA vers
Conditions
Interventions
Trade Name: Lidocain SAD
Product Name: Lidocain SAD
Product Code: 6730
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: LIDOCAINE HYDROCHLORIDE
CAS Number: 137-58-6
Current Sponsor code
Sponsors
Anders Gadegaard Jensen,Anesthesia and Intensive Care Unit, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing robotic assisted laparoscopic colon rectal cancer surgery and giving their informed consent to participate in the trial. Age = 18years of age. Danish-speaking patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Known hypersensitivity to the drug or local anesthetics of the amide type AV block Hepatic or renal impairment (ALT, AST, Bili> 2.5 x upper limit and CrCl <60ml / min) Durable consumption of opioids and NSAIDs Pregnancy or women of childbearing age without adequate contraception, breastfeeding women.Pregnancy test must be negative. Treatment with beta blockers Patients with known porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose of the trial is to investigate whether intravenous lidocaine administered perioperatively can significantly reduce postoperative morphine consumption during the first 24 hours postoperatively by robot-assisted laparoscopic colon rectal cancer surgery. ;Secondary Objective: Secondarily, we will examine whether this administration also significantly reduces morphine consumption up to 72 hours and reduces the duration of post-operative gastrointestinal dysfunction including reducing the incidence of post-operative nausea and vomiting as compared to placebo.;Primary end point(s): Reduction in pain intensity after the operation in terms of reduction in morphine consumption during the first 24 hours postoperatively.;Timepoint(s) of evaluation of this end point: The first 24 hours postoperatively for each patient included in the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduction in numerical rating scale (NRS), compared to placebo. Reduction in the duration of postoperative gastrointestinal dysfunction including a reduction in the consumption of anti-emetic therapy, as well as reduction in morphine consumption up to 72 hours postoperatively. Incidence of adverse reactions to the study drug are also recorded, if present.;Timepoint(s) of evaluation of this end point: 72 hours postoperatively for each patient included in the trial. | — |
Countries
Denmark
Contacts
Public ContactJan Herzog
Jan Herzog,Anesthesia and Intensive Care Unit, Odense University Hospital
Outcome results
None listed