Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
Condition: Primary Liver Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or
      the placebo group.

      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. In the
      placebo group, the same volume of normal saline will be administered during anesthesia.
    

Detailed description: 
      Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or
      the placebo group.

      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.

      Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of
      the surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood
      samples will also be collected 24 hours after surgery for subsequent measurement of IL-6, and
      tumor necrosis factor-α (TNF-α). The obtained samples will be labeled, centrifuged, frozen,
      and stored locally at -80° for subsequent testing.

      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.
    

Intervention name(s): Lidocaine Hydrochloride, Injectable; 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): lidocaine group; placebo group
Intervention MeSH terms: Lidocaine
Allocation: Randomized
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)
Primary purpose: Treatment