Lidocaine Infusion With ANI Monitoring in Spine Surgery.

Phase 4

Recruiting

• Conditions: Spine Surgery
• Interventions: Drug: Lidocaine HCl 2%; Drug: Normal saline

• Registration Number: NCT05103215
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Study Start: 2023-04-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine group	Lidocaine HCl 2%	Patients in the lidocaine group receive an intravenous injection of 1.5 mg/kg Lidocaine HCl 2% 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.
control group	Normal saline	Patients in control group receive the same volume of saline injection.

Primary Outcome Measures

Name	Time	Method
cumulative amount of opioids used	within 48 hours after operation	cumulative amount of opioids used after the operation
pain score	within 72 hours after operation	numerical rating scale, NRS, 0-10, higher score means worse outcome
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

Secondary Outcome Measures

Name	Time	Method
cumulative amount of remifentanil used	during operation	cumulative amount of remifentanil used
cumulative amount of propofol used	during operation	cumulative amount of propofol used
cumulative amount of rocuronium used	during operation	cumulative amount of rocuronium used
cumulative amount of opioids used	within 72 hours after operation	cumulative amount of opioids used after the operation

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan