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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369650
• Other study ID #: 2019-11
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2019
• Est. completion date: September 27, 2022

Study information

• Verified date: May 2022
• Source: West China Hospital
• Contact: Chunling Jiang, PhD
• Phone: 18980601096
• Email: jiang_chunling[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age: 18-70 years old
• American Society of Anesthesiologists(ASA) ?~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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate postoperative plasma lidocaine concentration	Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use	Immediately after surgery
Secondary	Plasma lidocaine concentration immediately after loading	Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use	30 minutes before surgery
Secondary	24-hour postoperative plasma lidocaine concentration	Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use	24-hour postoperative
Secondary	The incidence of lidocaine toxicity 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
Secondary	The incidence of moderate to severe pain at 24?48 and 72 hours after surgery at rest and during movement;	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
Secondary	The cumulative morphine consumption at 24, 48 and 72 hours postoperatively	intra-operative and postoperative opioid use is reported as morphine milligram	At the end of the surgery,24,48 and 72 hours after surgery
Secondary	Bowel function recovery	defined as the time to first defecation or time to first flatus	At 3 days after surgery
Secondary	Postoperative hospital stay	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
Secondary	Patient satisfaction scores	(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