The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Fentanyl consumption (measured as fentanyl equivalents -mcg)
Study Overview
Brief Summary
Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.
The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing laparoscopic cholecystectomy
Exclusion Criteria
- •age <18 yr or > 85 yr,
- •ASA physical status 3 and greater, history of hepatic failure (Child & Pug A-C),
- •renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
- •Adams-Stoke syndrome,
- •severe degrees of sinoatrial, atrioventricular or intraventricular block,
- •organ transplant,
- •diabetes mellitus type 1 and 2,
- •morbid obesity (BMI > 40),
- •chronic use of opioids and beta-blockers,
- •known seizures,
- •severe mental impairment,
- •allergy to local anesthetics and to all the medications used in the study, or
- •inability to understand pain assessment.
Arms & Interventions
Control
The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
Intervention: Fentanyl (Drug)
Lidocaine
The Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery
Intervention: Lidocaine (Drug)
Outcomes
Primary Outcomes
Fentanyl consumption (measured as fentanyl equivalents -mcg)
Time Frame: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery
Secondary Outcomes
- Pain, Static and Dynamic(On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery)
- Opioids side-effects(On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery)