Lidocaine Infusion With ANI Monitoring in Spine Surgery.

Spine Surgery Clinical Trial

Official title:

The Analgesic Effect of Intravenous Lidocaine Infusion in Combination of Analgesia Nociception Index Monitoring in Spine Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103215
• Other study ID #: KMUHIRB-F(I)-20210157
• Status: Recruiting
• Phase: Phase 4
• Start date: April 25, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Zhi-Fu Wu, MD
• Phone: 07-3121101
• Email: aneswu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Drug:
• Lidocaine 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.
• Normal 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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative amount of opioids used	cumulative amount of opioids used after the operation	within 48 hours after operation
Primary	the quality of recovery after the operation	Quality of recovery-15 score, QoR-15, 0-150, higher score means better outcome	on the third day after the operation
Primary	pain score	numerical rating scale, NRS, 0-10, higher score means worse outcome	within 72 hours after operation
Secondary	cumulative amount of opioids used	cumulative amount of opioids used after the operation	within 72 hours after operation
Secondary	cumulative amount of propofol used	cumulative amount of propofol used	during operation
Secondary	cumulative amount of remifentanil used	cumulative amount of remifentanil used	during operation
Secondary	cumulative amount of rocuronium used	cumulative amount of rocuronium used	during operation