Spine Surgery
Conditions
Keywords
Lidocaine, enhanced recovery after surgery
Brief summary
To evaluate the analgesic effect of intraoperative continuous lidocaine infusion (1.5 mg/kg/h (ideal body weight)) in combination of analgesia nociception index and depth of anesthesia monitors guided anesthetics adjustment on enhanced recovery after surgery (ERAS) in patients undergoing elective lumbar spine surgery (≥2 sessions).
Detailed description
The patients undergoing elective lumbar spine surgery (≥2 sessions) are randomly assigned and divided patients into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation. Patients in control group receive the same volume of saline injection. During the operation, the dose of anesthetic drugs (propofol, remifentanil and rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value, Entropy (or BIS) value at 40-60, and ANI at 50-70 in both groups. The pain score (numerical rating scale), cumulative amount of opioids used after the operation within 3 days, and the quality of recovery on the third day after the operation are recorded and analyzed.
Interventions
DRUGLidocaine HCl 2%
Intravenous injection of 1.5 mg/kg lidocaine at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.
DRUGNormal saline
Intravenous injection of 1.5 mg/kg normal saline at induction of anesthesia and continuous infusion of 1.5 mg/kg/h (ideal body weight) through the maintenance period to one hour after operation.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Twenty to eighty-year-old 2. ASA class I-III patients undergoing 3. Elective lumbar spine surgery under general anesthesia
Exclusion criteria
1. Unable to understand the Numerical Rating Scale (NRS) 2. Severe mental disorder 3. Poor liver function 4. Pregnant or lactating women 5. Morbidly obese 6. History of epilepsy or allergy to any of the drugs used in this study 7. Current use of opioids 8. Baseline heart rate \<50 beats/min 9. Arrhythmia history with cardiac rhythm device 10. Body weight \<40 kg and \>80kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative amount of opioids used | within 48 hours after operation | cumulative amount of opioids used after the operation |
| the quality of recovery after the operation | on the third day after the operation | Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome |
| pain score | within 72 hours after operation | numerical rating scale, NRS, 0-10, higher score means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cumulative amount of opioids used | within 72 hours after operation | cumulative amount of opioids used after the operation |
| cumulative amount of rocuronium used | during operation | cumulative amount of rocuronium used |
| cumulative amount of propofol used | during operation | cumulative amount of propofol used |
| cumulative amount of remifentanil used | during operation | cumulative amount of remifentanil used |
Countries
Taiwan
Contacts
Primary ContactZhi-Fu Wu, MD
Outcome results
None listed