a Pilot Study of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery

Sichuan University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Lidocaine Hydrochloride 2% Injection Solution; Drug: 0.9% NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT05412576

2020-1180

Details and patient eligibility

About

patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery

Full description

patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery. Subsequently, all subjects will receive an analgesic device named Patient-Controlled Intravenous Analgesia pump, briefly, PCIA pump during the first 72 postoperative hours. PCIA pump contains lidocaine 30mg/kg, sufentanil 2 μg/kg, and granisetron 12 mg diluted to 200 mL in 0.9 % normal saline, while in the placebo group, the lidocaine will be replaced with the equal dose of 0.9% normal saline and other components unchanged. All the background infusions of PCIA will be set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Enrollment: 220 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 60 years old；
• American Society Anesthesiologygist(ASA)I~III；
• Patients scheduled for colorectal cancer surgery；
• The surgery takes more than two hours

Exclusion criteria

• BMI≥30kg/㎡or BMI≤18kg/㎡；
• Combined with other organ malignancies；
• Chronic opioid use, substance abuse, contraindication to the use or incompatibility of any drug in the study；
• Patients with liver and kidney insufficiency and chronic pain at the surgical site；
• Accompanied by severe heart disease (such as severe atrioventricular block, severe heart failure, etc.)；
• A history of uncontrolled seizures or acute porphyria；
• Patients who have taken other experimental drugs or participated in or are participating in other clinical trials within 3 months before being enrolled in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 4 patient groups, including a placebo group

IVL0.5 group

Experimental group

Description:

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Treatment:

Drug: Lidocaine Hydrochloride 2% Injection Solution

IVL1.0 group

Experimental group

Description:

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Treatment:

Drug: Lidocaine Hydrochloride 2% Injection Solution

IVL1.5 group

Experimental group

Description:

At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.

Treatment:

Drug: Lidocaine Hydrochloride 2% Injection Solution

Placebo group

Placebo Comparator group

Description:

At the beginning of surgery, in the placebo group, the same dose of normal saline as the experimental groups will be given until the procedure is over.

Treatment:

Drug: 0.9% NaCl