Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

Primary Liver Cancer Clinical Trial

Official title:

Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295330
• Other study ID #: 2018HXFH046
• Status: Completed
• Phase: N/A
• Start date: February 27, 2020
• Est. completion date: May 27, 2022

Study information

• Verified date: August 2022
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 18-80 years old
• American Society of Anesthesiologists(ASA) ?~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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Primary Liver Cancer

Intervention

Drug:
• Lidocaine Hydrochloride, Injectable
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.
• 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.

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	The primary outcome is the incidence of moderate to severe pain (NRS = 4) during movement (i.e. deep breathing) at 24 hours after surgery.	The 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.	The first 24 hours after surgery
Secondary	The incidence of moderate to severe pain at 24 hours after surgery at rest	The 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.	The first 24 hours after surgery
Secondary	The incidence of moderate to severe pain at 48 and 72 hours after surgery at rest and during movement;	The 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.	At 3 days 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 equivalents, calculated using the Practical Pain Management calculator	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	The incidence of PONV during the first 72 hours after surgery	we considered it PONV if patients felt any nausea or had any vomiting	At 3 days after surgery
Secondary	The incidence of a composite of postoperative pulmonary complications during hospitalization	defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, immediately after the end of surgery, and at the first 24 hours after surgery	during the period from the end of surgery to discharge
Secondary	Length of hospital stay	determined by the number of days from admittance to discharge	during the period from the end of surgery to discharge
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 and before discharge
Secondary	Levels of inflammatory factors ( IL-6, TNF-a) at 24 hours after surgery.	Levels of inflammatory factors ( IL-6, TNF-a) at 24 hours after surgery.	at 24 hours after surgery.