Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy
Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy
Sponsors
Source
West China Hospital
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
This study is a further observation and follow-up of the patients enrolled in the
registration number NCT04295330 to further evaluate the effect of long-term infusion of
lidocaine on postoperative chronic pain, long-term quality of life and survival rate in
patients undergoing liver cancer surgery.
Detailed Description
This study is a further observation and follow-up of the patients enrolled in the
registration number NCT04295330 to further evaluate the effect of long-term infusion of
lidocaine on postoperative chronic pain, long-term quality of life and survival rate in
patients undergoing liver cancer surgery. 272 patients with primary liver cancer who meet
the inclusion criteria are included. According to the random number, the patients are
divided into lidocaine group and conventional analgesia group.In the lidocaine group, a
bolus injection of lidocaine 1.5 mg/kg, given as an infusion over 10 minutes, followed by
a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure
and will be discontinued at the end of surgery. Postoperative pain management during the
first 72 postoperative hours will involve the use of a PCIA device, which will contain
lidocaine , sufentanil , granisetron diluted to 200 mL in 0.9 % normal saline. In the
placebo group, the same volume of normal saline instead of lidocaine will be
administered. Blood samples will be drawn immediately after the bolus infusion of
lidocaine, at the end of surgery, and 24 hours after surgery to measure plasma lidocaine
concentrations. Blood samples will also be collected at 24 hours after surgery for
subsequent measurement of inflammatory factors. Numeric rating scale(NRS) is used to
evaluate pain at rest and light activities at postoperative 24, 48, 72 hours. The
recovery time of postoperative gastrointestinal function, length of hospital stay, and
the incidence of lidocaine toxicity within postoperative 72 hours will be recorded.
Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of
life, the relapse-free survival and overall survival from postoperative 3 months to 5
years.
Overall Status
Recruiting
Start Date
2020-02-27
Completion Date
2024-07-27
Primary Completion Date
2024-07-27
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
The incidence of chronic pain at 3 months postoperatively |
3 months postoperatively |
Secondary Outcome
Measure |
Time Frame |
|
The incidence of chronic pain at 6 months ,1 year,3 year and 5 year postoperatively |
6 months, 1 year and 3 year postoperatively |
|
The levels of inflammatory factors at 24 hours after surgery |
24 hours postoperatively |
|
The incidence of moderate to severe pain at 24, 48 and 72 hours after surgery at rest and during movement; |
At 3 days after surgery |
|
The cumulative morphine consumption at 24, 48 and 72 hours postoperatively |
At the end of the surgery，24，48 and 72 hours after surgery |
|
The incidence of a composite of postoperative pulmonary complications during |
during the period from the end of surgery to discharge |
|
Length of hospital stay |
during the period from the end of surgery to discharge |
|
Plasma lidocaine concentration immediately after loading，after surgery and 24-hours postoperatively |
Immediately after bolus, after surgery and 24-hour postoperatively |
|
The incidence of lidocaine toxicity within 72 hours after operation |
within 72 hours after operation |
|
Overall survival after surgery |
6 months, 1 year, 3 years, 5 years postoperatively |
|
Recurrence-free survival after surgery |
6 months, 1 year, 3 years, 5 years postoperatively |
|
Disability-free surviva survival |
6 months, 1 year, 3 years, 5 years postoperatively |
Enrollment
260
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
In the lidocaine group, at the end of the induction of general anesthesia, a bolus
injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and
given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at
1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end
of surgery. 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.
Arm Group Label
Lidocaine group
Other Name
lidocaine group
Intervention Type
Drug
Intervention Name
Description
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.
Arm Group Label
Conventional analgesia group
Other Name
placebo group
Eligibility
Criteria
Inclusion Criteria:
Age: 18-80 years old American Society of Anesthesiologists(ASA) Ⅰ～III BMI≤30 Primary
single hepatocellular carcinoma resection was proposed for patients undergoing laparotomy
(median incision, right subcostal incision/inverted L-shaped incision)
Exclusion Criteria:
Primary liver cancer with malignant tumors of other organs (such as lung, kidney,
intestine, etc.).
Primary hepatocellular carcinoma with portal vein or inferior vena cava and other large
vascular thrombus.
Long-term opioid use, alcohol or drug abuse or any of the drugs (lidocaine, etc.) used in
this study were contraindicated and allergic for patients.
Patients with severe hepatic and renal dysfunction (total bilirubin >1.46mg/dl,
glomerular filtration rate <30ml/min /1.73㎡ or end-stage renal disease).
Severe heart disease (severe heart block (including sinoatrial, atrioventricular, and
intraventricular block); Severe heart failure (ejection fraction <20%); Sinus
bradycardia; Patients with Adams-Stokes syndrome, preexcitation syndrome, etc Patients
with a history of uncontrolled seizures or acute porphyria. Long-term use of cimetidine
and β-blockers (lidocaine metabolism is inhibited through the liver, resulting in
increased blood concentration of the drug, which can lead to adverse cardiac and nervous
system reactions).
Patients treated with drugs that are contraindicated with lidocaine (phenobarbital,
thiopental, sodium nitroprusside, mannitol, amphotericin B, ampicillin, mesonotal,
sulfadiazine sodium); Patients who are using enoxacin, lomefloxacin, norfloxacin, and
prulifloxacin.
Patients with a history of gastrointestinal bleeding or perforation after nsaids;Patients
with active gastrointestinal ulcers/bleeding or who have had recurrent ulcers/bleeding in
the past.
Patients who had taken other experimental drugs or were participating or participating in
other clinical trials within 3 months of enrollment.
Failure to cooperate with the study for any reason or the researcher considers it
inappropriate to be included in the study.
Gender
All
Minimum Age
18 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Chunling Jiang, PhD |
Study Director |
West China Hospital |
Overall Contact
Last Name
Chunling Jiang, PhD
Phone
18980601096
jiang_chunling@yahoo.com
Location
Facility |
Status |
Contact |
|
West China Hospital Chengdu 1815286 Sichuan 1794299 610041 China |
Recruiting |
Last Name: Chunling Jiang, PhD Phone: 18980601096 Email: jiang_chunling@yahoo.com |
Location Countries
Country
China
Verification Date
2024-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
West China Hospital
Investigator Full Name
Chunling Jiang
Investigator Title
Professor
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Lidocaine
Injections
Saline Solution
Arm Group
Arm Group Label
Lidocaine group
Arm Group Type
Experimental
Description
General anesthesia is induced in the lidocaine group with intravenous lidocaine 1.5mg/kg
for ten minutes, followed by continuous injection of lidocaine 1.5mg/kg.h. At the end of
the operation, the patient controlled intravenous analgesia with lidocaine is used, and
the dose of lidocaine is 30mg/kg(no more than 2000mg at most).
Arm Group Label
Conventional analgesia group
Arm Group Type
Placebo Comparator
Description
The lidocaine is replaced by identical volumes and rates of 0.9% saline. At the end of
the operation, the patient controlled intravenous analgesia without lidocaine is used.
Firstreceived Results Date
N/A
Other Outcome
Measure
The prevalence of neuropathic pain
Time Frame
3 months, 6 months, 1 year, 3 years, 5 years postoperatively
Description
The ID Pain scale is used as a validated assessment of neuropathic pain. ID pain
questionnaire consists of six items. Pain higher scores suggest a neuropathic component
to the pain.
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The experimental group received lidocaine and the control group received the same amount
of saline.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The participants, the anesthesiologist, data collectors, the physicians performing the
follow-up, and data analysts will be blinded to the group allocation. Blinding will
maintain until the completion of the final analyses.
Study First Submitted
August 5, 2022
Study First Submitted Qc
August 5, 2022
Study First Posted
August 8, 2022
Last Update Submitted
April 17, 2024
Last Update Submitted Qc
April 17, 2024
Last Update Posted
April 19, 2024
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.