LidocaineNCT04008433
Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
A study testing Lidocaine in people with Lidocaine and Injection Pain, run by Yangzhou University at 1 site in China.
Trial summary
Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lidocaine, Injection Pain
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2018to 13 Jun 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages ranged from 18 to 65.
- ASA Ⅰ or Ⅱ level.
Who cannot join
- Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;
- Abnormal liver or kidney function;
- Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
- Hearing and language impairment;
- Peripheral vascular disease;
- Severe cardiovascular disease or neurological disorders;
- Failure of one-time peripheral venipuncture;
- Infection of hand or wrist skin.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, 225012
About this study
Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.
- Conditions
- Lidocaine, Injection Pain
- Being tested
- Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Advanced intravenous injection of lidocaine before the propofol injection
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine pre-intravenous injection | Experimental | The initial dose of lidocaine for pre-injection was set at 0.5mg /kg according to previous literature and preliminary test results. The dose of lidocaine was according to the patients' pain level. If there is no pain (negative reaction), the dose of lidocaine in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of lidocaine will be increased in the next patient until the patient is painless. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The appearance of intravenous injection pain
Yes or No
Measured: through study completion, an average of 2 minutes
Secondary outcomes (2)
The levels of intravenous injection pain
The intravenous injection pain in this study was divided into the following 5 levels according to its severity: level 0: After repeated questioning, the patient did not feel any abnormal sensation; level 1: upon inquiry, the patient felt swelling at the intravenous injection site; Level 2: Upon inquiry, the patient felt pain and had no body movement reaction (facial pain expression, arm withdrawal, tears, etc.); Level 3: Upon inquiry, the patient had pain and body movement reaction. Or complain of pain without inquiry; Level 4: the patient has a strong reaction and body movement reaction. Level 2 and above is defined as injection pain.
Measured: through study completion, an average of 2 minutes
If any adverse memory or pain during the induction of general anesthesia
Patients recalled by visual analogue scale (VAS) to assess injection pain level : Mark 0 is painless. Mark 10 is violent pain, The numbers between them was pain of varying degrees.
Measured: Before patients left the postanesthetic care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start16 Nov 2018
- Primary completion16 Nov 2018
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LidocaineStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008433
- Sponsor's protocol ID
- 20190604
- Status last verified
- Jan 2020
- First submitted
- 27 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Effective Dose of Lidocaine for the Prevention of Pain Caused by the Injection of Propofol Formulated With Medium-/Long-chain Triglycerides
- ClinicalTrials.gov ID
- NCT04008433
- Acronym / sponsor ID
- 20190604
- Conditions
- Lidocaine, Injection Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 5 Jul 2019 (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.
Propofol is widely used in general anesthesia induction, but the occurrence of peripheral intravenous pain is relatively high, causing anxiety, fear and other adverse emotions in patients , aggravating the stress response, and even leading to adverse events of cardiovascular system . The use of mediate-long chain fat emulsion propofol partly reduces the incidence of injection pain but patients can still suffer from different degrees of pain. Advanced intravenous injection of lidocaine can alleviate the pain of propofol injection, but its application method and dose are controversial. It is worthy of further discussion on how to select the appropriate dose of advanced intravenous injection of lidocaine to effectively prevent the injection pain of mediate-long chain fat emulsion propofol, and simultaneously avoid the adverse reactions of intravenous lidocaine, thus improving patient satisfaction and perioperative safety. In this study, in order to provide clinical references, sequential method was used to find the median effective dose (ED50) by means of pre-intravenous injection of lidocaine to suppress pain in mediate-long chain fat emulsion propofol injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine pre-intravenous injection | Experimental | Drug: LidocaineThe initial dose of lidocaine for pre-injection was set at 0.5mg /kg according to previous literature and preliminary test results. The dose of lidocaine was according to the patients' pain level. If there is no pain (negative reaction), the dose of lidocaine in the next patient will be reduced until the patient has pain. If there is pain (positive reaction), the dose of lidocaine will be increased in the next patient until the patient is painless. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages ranged from 18 to 65.
- ASA Ⅰ or Ⅱ level.
Key exclusion criteria (8 listed)
- Allergy or contraindication to lidocaine or propofol; required for Central venipuncture catheterization;
- Abnormal liver or kidney function;
- Heavy drinking and long-term use of sedatives, analgesics or anti-anxiety drugs;
- Hearing and language impairment;
- Peripheral vascular disease;
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 |
|---|---|---|
| LidocaineAdvanced intravenous injection of lidocaine before the propofol injection | Drug | Lidocaine pre-intravenous injection |
Primary outcome
The appearance of intravenous injection pain
Time frame: through study completion, an average of 2 minutes
Yes or No
2 secondary outcomes
The levels of intravenous injection pain
Time frame: through study completion, an average of 2 minutes
If any adverse memory or pain during the induction of general anesthesia
Time frame: Before patients left the postanesthetic care unit (PACU)
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 5 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Lidocaine and Injection Pain, run by Yangzhou University 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 2 inclusion and 8 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 5 Feb 2020. 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. 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 appearance of intravenous injection pain (time frame: through study completion, an average of 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.