Clinical trial NCT05369650: To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients
Official title: A Pilot Study on the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine for Postoperative Analgesia in Patients With Open Hepatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental patients are randomly divided into three groups and received different doses of lidocaine and the control group received the same amount of saline.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate postoperative plasma lidocaine concentration
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Plasma lidocaine concentration immediately after loading
timeFrame: 30 minutes before surgery
measure: 24-hour postoperative plasma lidocaine concentration
timeFrame: 24-hour postoperative
measure: The incidence of lidocaine toxicity within 72 hours after operation
timeFrame: within 72 hours after operation
measure: The incidence of moderate to severe pain at 24、48 and 72 hours after surgery at rest and during movement;
timeFrame: 24，48 and 72 hours after surgery
measure: The cumulative morphine consumption at 24, 48 and 72 hours postoperatively
timeFrame: At the end of the surgery，24，48 and 72 hours after surgery
measure: Bowel function recovery
timeFrame: At 3 days after surgery
measure: Postoperative hospital stay
timeFrame: up to 30 days
measure: Patient satisfaction scores
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Chunling Jiang, PhD
role: STUDY_DIRECTOR
References: