To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients

May 10, 2022 updated by: Chunling Jiang, West China Hospital

A Pilot Study on the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine for Postoperative Analgesia in Patients With Open Hepatectomy

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-70 years old
  • American Society of Anesthesiologists(ASA) Ⅰ～III
  • BMI≤30
  • Intended for open liver resection Exclusion criteria：1. Long-term opioid users 2. Patients with contraindications or allergies to any drugs (lidocaine, etc.) used in this study 3. Patients with severe hepatic insufficiency before surgery (defined as total bilirubin>1.46mg/dl), renal insufficiency (glomerular filtration rate <30ml/min/1.73m2 or end-stage renal disease) 4. Associated with severe heart disease (second or third degree atrioventricular block); severe heart failure (ejection fraction <50%); sinus bradycardia; patient 6. Patients who participated in other clinical trials within 3 months before enrollment in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lidocaine 1 group
After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.
Drug: Lidocaine Hydrochloride, Injectable
The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.
EXPERIMENTAL: Lidocaine 1.5 group
After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1.5mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.
Drug: Lidocaine Hydrochloride, Injectable
The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.
EXPERIMENTAL: Lidocaine 2 group
After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 2mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.
Drug: Lidocaine Hydrochloride, Injectable
The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immediate postoperative plasma lidocaine concentration
Time Frame: Immediately after surgery
Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
Immediately after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bowel function recovery
Time Frame: At 3 days after surgery
defined as the time to first defecation or time to first flatus
At 3 days after surgery
Plasma lidocaine concentration immediately after loading
Time Frame: 30 minutes before surgery
Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
30 minutes before surgery
24-hour postoperative plasma lidocaine concentration
Time Frame: 24-hour postoperative
Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
24-hour postoperative
The incidence of lidocaine toxicity within 72 hours after operation
Time Frame: within 72 hours after operation
Lidocaine toxicity mainly includes neurological manifestations such as dizziness, tinnitus, convulsions, cardiac manifestations such as bradycardia, new severe atrioventricular block and so on.
within 72 hours after operation
The incidence of moderate to severe pain at 24、48 and 72 hours after surgery at rest and during movement;
Time Frame: 24，48 and 72 hours after surgery
he pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
24，48 and 72 hours after surgery
The cumulative morphine consumption at 24, 48 and 72 hours postoperatively
Time Frame: At the end of the surgery，24，48 and 72 hours after surgery
intra-operative and postoperative opioid use is reported as morphine milligram
At the end of the surgery，24，48 and 72 hours after surgery
Postoperative hospital stay
Time Frame: up to 30 days
The days of hospital stay after the operation were calculated from the first day after the operation to the days of discharge.
up to 30 days
Patient satisfaction scores
Time Frame: 72 hours after surgery
(satisfaction scores regarding pain control and the overall recovery process were obtained at 72 hours after surgery, using a 11-point Likert scale, with 0 indicating "very dissatisfied"and10 indicating "very satisfied"
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-11 (APHM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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