Clinical trial NCT04295330: Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
Official title: Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Liver Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group received lidocaine and the control group received the same amount of saline.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years old
* American Society of Anesthesiologists(ASA) Ⅰ～III
* patients scheduled for elective hepatectomy

Exclusion Criteria:

• body weight \< 40 kg or \>100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin \> 2.5 times the upper limit of normal), renal impairment (creatinine clearance \< 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction \< 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.

Primary outcomes:
measure: The primary outcome is the incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. deep breathing) at 24 hours after surgery.
timeFrame: The first 24 hours after surgery
Secondary outcomes:
measure: The incidence of moderate to severe pain at 24 hours after surgery at rest
timeFrame: The first 24 hours after surgery
measure: The incidence of moderate to severe pain at 48 and 72 hours after surgery at rest and during movement;
timeFrame: At 3 days 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: The incidence of PONV during the first 72 hours after surgery
timeFrame: At 3 days after surgery
measure: The incidence of a composite of postoperative pulmonary complications during hospitalization
timeFrame: during the period from the end of surgery to discharge
measure: Length of hospital stay
timeFrame: during the period from the end of surgery to discharge
measure: Patient satisfaction scores
timeFrame: 72 hours after surgery and before discharge
measure: Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery.
timeFrame: at 24 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: