Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy

NCT05492669 | Recruiting Phase 2 DMC

• 1 other identifier: 2019-571
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Chronic Pain

Keywords

lidocaine

Outcome Measures

Primary Outcomes (1)

• The incidence of chronic pain at 3 months postoperatively

  Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience. The impact of chronic pain on the quality of life is also assessed by Brief Pain Inventory score.

  3 months postoperatively

Secondary Outcomes (11)

• 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

Other Outcomes (1)

• The prevalence of neuropathic pain

  3 months, 6 months, 1 year, 3 years, 5 years postoperatively

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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).

Drug: Lidocaine Hydrochloride, Injectable

Conventional analgesia group

PLACEBO COMPARATOR

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.

Drug: 0.9% normal saline

Interventions

Lidocaine Hydrochloride, Injectable DRUG

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.

Also known as: lidocaine group

Lidocaine group

0.9% normal saline DRUG

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.

Also known as: placebo group

Conventional analgesia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Injections; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The experimental group received lidocaine and the control group received the same amount of saline.

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: February 27, 2020
• Primary Completion: July 27, 2024
• Study Completion: July 27, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)