Primary Liver CancerNCT04295330
Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy
A study testing Lidocaine Hydrochloride, Injectable and 0.9% normal saline in people with Primary Liver Cancer, run by West China Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Liver Cancer
- What is being tested?
- Lidocaine Hydrochloride, Injectable and 0.9% normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2020to 27 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old
- American Society of Anesthesiologists(ASA) Ⅰ～III
- patients scheduled for elective hepatectomy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study
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.
Read the 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.
- Conditions
- Primary Liver Cancer
- Being tested
- Lidocaine Hydrochloride, Injectable, 0.9% normal saline
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride, InjectableDrug
Also called lidocaine 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. 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 salineDrug
Also called placebo group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lidocaine Hydrochloride, Injectable |
| placebo group | Placebo comparator | the same volume of normal saline will be administered during anesthesia. Receives: Drug: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The first 24 hours after surgery
Secondary outcomes (9)
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.
Measured: 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;
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.
Measured: At 3 days after surgery
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
Measured: At the end of the surgery，24，48 and 72 hours after surgery
Bowel function recovery
defined as the time to first defecation or time to first flatus
Measured: At 3 days after surgery
The incidence of PONV during the first 72 hours after surgery
we considered it PONV if patients felt any nausea or had any vomiting
Measured: At 3 days after surgery
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
Measured: during the period from the end of surgery to discharge
Length of hospital stay
determined by the number of days from admittance to discharge
Measured: during the period from the end of surgery to discharge
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"
Measured: 72 hours after surgery and before discharge
Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery.
Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery.
Measured: at 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start27 Feb 2020
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Liver CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group received lidocaine and the control group received the same amount of saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295330
- Sponsor's protocol ID
- 2018HXFH046
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37202261
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04295330
- Acronym / sponsor ID
- 2018HXFH046
- Conditions
- Primary Liver Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The experimental group received lidocaine and the control group received the same amount of saline.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: Lidocaine Hydrochloride, Injectableat 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. |
| placebo group | Placebo comparator | Drug: 0.9% normal salinethe same volume of normal saline will be administered during anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-80 years old
- American Society of Anesthesiologists(ASA) Ⅰ～III
- patients scheduled for elective hepatectomy
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Hydrochloride, InjectableAlso: lidocaine groupIn 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. | Drug | Lidocaine group |
| 0.9% normal salineAlso: placebo groupIn 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. | Drug | placebo group |
Primary outcome
The primary outcome is the incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. deep breathing) at 24 hours after surgery.
Time frame: The first 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.
9 secondary outcomes
The incidence of moderate to severe pain at 24 hours after surgery at rest
Time frame: 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;
Time frame: At 3 days after surgery
The cumulative morphine consumption at 24, 48 and 72 hours postoperatively
Time frame: At the end of the surgery，24，48 and 72 hours after surgery
Bowel function recovery
Time frame: At 3 days after surgery
The incidence of PONV during the first 72 hours after surgery
Time frame: At 3 days after surgery
The incidence of a composite of postoperative pulmonary complications during hospitalization
Time frame: during the period from the end of surgery to discharge
Length of hospital stay
Time frame: during the period from the end of surgery to discharge
Patient satisfaction scores
Time frame: 72 hours after surgery and before discharge
Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery.
Time frame: at 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 37202261Xu 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.
- Individual participant dataSharing planned: No
Related trials for Primary Liver Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
A Retrospective Registry of Intelliblate DUAL Channel Microwave Ablation
Liver Ablation, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunling Jiang, PhD study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Hydrochloride, Injectable and 0.9% normal saline in people with Primary Liver Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: The first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.