Intravenous Lidocaine on Chronic Pain in Patients Undergoing Hepatectomy
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|ClinicalTrials.gov Identifier: NCT05492669|
Recruitment Status : Recruiting
First Posted : August 8, 2022
Last Update Posted : August 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Chronic Pain||Drug: Lidocaine Hydrochloride, Injectable Drug: 0.9% normal saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||272 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The experimental group received lidocaine and the control group received the same amount of saline.|
|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.|
|Official Title:||Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy|
|Actual Study Start Date :||February 27, 2020|
|Estimated Primary Completion Date :||July 27, 2024|
|Estimated Study Completion Date :||July 27, 2024|
Experimental: Lidocaine group
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
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.
Other Name: lidocaine group
Placebo Comparator: Conventional analgesia group
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
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.
Other Name: placebo group
- The incidence of chronic pain at 3 months postoperatively [ Time Frame: 3 months postoperatively ]Chronic pain is deﬁned as pain that lasts or recurs for longer than 3 months . For CPSP, it mainly refers to the pain that persists past normal healing time.Pain scoring is performed at 3 months using the Digital Evaluation 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 incidence of chronic pain at 6 months , 1 year, 3 year and 5year postoperatively [ Time Frame: 6 months, 1 year and 3 year postoperatively ]Chronic pain is deﬁned as pain that lasts or recurs for longer than 3 months. For CPSP, it mainly refers to the pain that persists past normal healing time.Pain scoring is performed at 6 months postoperatively using the Digital Evaluation 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 levels of inflammatory factors at 24 hours after surgery [ Time Frame: 24 hours postoperatively ]Peripheral blood NK cells, TNF-α, CXCL10, CX3CL1, cytokines IL-6, IL-8, C3a, C5a, P(CD62P)-selectin, NETosis-specific indicators (MPO and Histone H3), three tumor progressions and metastasis-related markers (VEGF-A, MMP-3, MMP-9,MMP-2) are measured 24 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: At 3 days after surgery ]The 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
- 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 ]Intraoperative and postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
- The incidence of a composite of postoperative pulmonary complications during [ Time Frame: during the period from the end of surgery to discharge ]defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery
- Length of hospital stay [ Time Frame: during the period from the end of surgery to discharge ]determined by the number of days from admittance to discharge
- Plasma lidocaine concentration immediately after loading，after surgery and 24-hours postoperatively [ Time Frame: Immediately after bolus, after surgery and 24-hour postoperatively ]Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use.
- 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.
- Overall survival [ Time Frame: 6 months, 1 year, 3 years, 5 years postoperatively ]Overall survival is defined as the time between the date od surgery and the date of death
- Recurrence-free survival [ Time Frame: 6 months, 1 year, 3 years, 5 years postoperatively ]Postoperative re-examination is based on the diagnosis of enhanced CT, MRI, ultrasound or blood examination to determine whether the patient has recurrence and metastasis. Recurrence-free time refers to the time from surgery to tumor recurrence based on the above CT, MRI, etc.
- accessible survival [ Time Frame: 3 months, 6 months, 1 year, 3 years, 5 years postoperatively ]Patient self-assessment is carried out by using the World Health Organization(WHO) Disability Scale, with a minimum score of 12 points and a maximum score of 60 points. The lower the score, the higher the quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05492669
|Contact: Chunling Jiang, PhDfirstname.lastname@example.org|
|West China Hospital||Recruiting|
|Chengdu, Sichuan, China, 610041|
|Contact: Chunling Jiang, PhD 18980601096 email@example.com|
|Study Director:||Chunling Jiang, PhD||West China Hospital|