Injection Site IrritationPhase 2/3NCT04356352
Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain
A Phase 2/3 study testing Lidocaine and Esmolol in people with Injection Site Irritation and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Injection Site Irritation, Pain
- What is being tested?
- Lidocaine and Esmolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 25 Aug 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age
- ASA 1-3
- Elective surgical procedure
Who cannot join
- BMI ≥ 45
- Pregnancy
- Requirement for RSI or awake intubation
- Suspected or known difficult airway
- Contraindication to IV in either upper extremity
- Chronic pain syndrome including fibromyalgia
Show all 10Show fewer
- Use of opioids, NSAIDs, or other analgesics within 24 hours (including preoperative PO Celebrex, Lyrica, Tylenol, etc.)
- Any use of opioids in the past three months
- Significant cardiopulmonary or hepatic dysfunction
- Hypersensitivity to study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool
Read the detailed description
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered
- Conditions
- Injection Site Irritation, Pain
- Being tested
- Lidocaine, Esmolol, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
EsmololDrug
0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
PlaceboOther
saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | 1 mg/kg lidocaine to a max of 100 mg Receives: Drug: Lidocaine |
| Esmolol | Active comparator | 0.5 mg/kg esmolol to a max of 50 mg Receives: Drug: Esmolol |
| Placebo | Placebo comparator | Saline water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Score
pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
Measured: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
Secondary outcomes (3)
Heart Rate
heart rate is measured as numbers on a scale with normal 60-100
Measured: heart rate is measured each minute for the first 10 minutes following induction
Systolic Blood Pressure
blood pressure measured in mmHg
Measured: Systolic Blood Pressure is measured each minute for the first 10 minutes following induction
Oxygen Saturation Percentage
oxygen saturation is measured on a percentage, with normal range >90%
Measured: Oxygen saturation measured each minute for the first 10 minutes following induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start9 Sep 2020
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Why it stopped: feasibility of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Norton, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356352
- Sponsor's protocol ID
- IRB00063576
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Lidocaine, Esmolol, and Placebo Without Use of a Tourniquet for Relieving Pain From Intravenous Administration of Propofol
- ClinicalTrials.gov ID
- NCT04356352
- Acronym / sponsor ID
- IRB00063576
- Conditions
- Injection Site Irritation, Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility of enrollment
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis is that esmolol and lidocaine, when given without the use of a tourniquet, provide relief of propofol injection pain that is superior to placebo when assessed using the propofol pain scoring tool
Detailed description
The study will include three arms: lidocaine, esmolol, and placebo. Eligible patients will be 18-60 years old, ASA physical status 1-3, and scheduled for an elective surgical procedure. Patients will be randomized to receive lidocaine, esmolol, or placebo. Both the patients and the administering/observing providers will be blinded to the study drug or placebo being administered
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- subjects randomized to receive either lidocaine, esmolol, or placebo immediately prior to the administration of propofol for their surgical procedure to treat injection site pain caused by propofol
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine1 mg/kg lidocaine to a max of 100 mg |
| Esmolol | Active comparator | Drug: Esmolol0.5 mg/kg esmolol to a max of 50 mg |
| Placebo | Placebo comparator | Other: PlaceboSaline water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years of age
- ASA 1-3
- Elective surgical procedure
Key exclusion criteria (10 listed)
- BMI ≥ 45
- Pregnancy
- Requirement for RSI or awake intubation
- Suspected or known difficult airway
- Contraindication to IV in either upper extremity
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 |
|---|---|---|
| Lidocaine1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | Drug | Lidocaine |
| Esmolol0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | Drug | Esmolol |
| Placebosaline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered. | Other | Placebo |
Primary outcome
Patient Pain Score
Time frame: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction
pain scoring system previously used by studies looking at various remedies to decrease Propofol injection pain - 0-10 with 0=no pain up to 10=worst pain imaginable
3 secondary outcomes
Heart Rate
Time frame: heart rate is measured each minute for the first 10 minutes following induction
Systolic Blood Pressure
Time frame: Systolic Blood Pressure is measured each minute for the first 10 minutes following induction
Oxygen Saturation Percentage
Time frame: Oxygen saturation measured each minute for the first 10 minutes following induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Michael Norton, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine and Esmolol in people with Injection Site Irritation and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
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 10 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Pain Score (time frame: following administration of a sub-induction dose of propofol, 0.5 mg/kg up to 50 mg, just prior to full induction). 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 19 Sep 2024.