NCT05103215

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

October 21, 2021

Last Update Submit

March 19, 2024

Conditions

Spine Surgery

Keywords

Lidocaine, enhanced recovery after surgery

Outcome Measures

Primary Outcomes (3)

  • cumulative amount of opioids used

    cumulative amount of opioids used after the operation

    within 48 hours after operation

  • 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

  • pain score

    numerical rating scale, NRS, 0-10, higher score means worse outcome

    within 72 hours after operation

Secondary Outcomes (4)

  • cumulative amount of opioids used

    within 72 hours after operation

  • cumulative amount of propofol used

    during operation

  • cumulative amount of remifentanil used

    during operation

  • cumulative amount of rocuronium used

    during operation

Study Arms (2)

lidocaine group

EXPERIMENTAL

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.

Drug: Lidocaine HCl 2%

control group

PLACEBO COMPARATOR

Patients in control group receive the same volume of saline injection.

Drug: Normal saline

Interventions

Lidocaine HCl 2%DRUG

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.

Also known as: Xylocaine Injection 2%
lidocaine group
Normal salineDRUG

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.

Also known as: 0.9% Normal Saline (20mL)
control group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Twenty to eighty-year-old
  • ASA class I-III patients undergoing
  • Elective lumbar spine surgery under general anesthesia

You may not qualify if:

  • Unable to understand the Numerical Rating Scale (NRS)
  • Severe mental disorder
  • Poor liver function
  • Pregnant or lactating women
  • Morbidly obese
  • History of epilepsy or allergy to any of the drugs used in this study
  • Current use of opioids
  • Baseline heart rate \<50 beats/min
  • Arrhythmia history with cardiac rhythm device
  • Body weight \<40 kg and \>80kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zhi-Fu Wu, MD

    Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung City, Taiwan (R.O.C.)

    STUDY CHAIR

Central Study Contacts

Zhi-Fu Wu, MD

CONTACT

07-3121101aneswu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

April 25, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)