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

NCT04295330 | Completed

• 1 other identifier: 2018HXFH046
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The incidence of moderate to severe pain at 24 hours after surgery at rest

  The first 24 hours after surgery

• The incidence of moderate to severe pain at 48 and 72 hours after surgery at rest and during movement;

  At 3 days after surgery

• The cumulative morphine consumption at 24, 48 and 72 hours postoperatively

  At the end of the surgery，24，48 and 72 hours after surgery

• Bowel function recovery

  At 3 days after surgery

• The incidence of PONV during the first 72 hours after surgery

  At 3 days after surgery

Study Arms (2)

Lidocaine group

EXPERIMENTAL

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.

Drug: Lidocaine Hydrochloride, Injectable

placebo group

PLACEBO COMPARATOR

the same volume of normal saline will be administered during anesthesia.

Drug: 0.9% normal saline

Interventions

Lidocaine Hydrochloride, Injectable DRUG

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.

Also known as: lidocaine group

Lidocaine group

0.9% normal saline DRUG

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.

Also known as: placebo group

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Xu Y, Ye M, Liu F, Hong Y, Kang Y, Li Y, Li H, Xiao X, Yu F, Zhou M, Zhou L, Jiang C. Efficacy of prolonged intravenous lidocaine infusion for postoperative movement-evoked pain following hepatectomy: a double-blinded, randomised, placebo-controlled trial. Br J Anaesth. 2023 Jul;131(1):113-121. doi: 10.1016/j.bja.2023.03.026. Epub 2023 May 16.

  PMID: 37202261 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Lidocaine; Injections; Saline Solution

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The experimental group received lidocaine and the control group received the same amount of saline.

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: March 4, 2020
• Study Start: February 27, 2020
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)