Propofol Injection PainNCT07785674
Arm Elevation for Prevention of Propofol Injection Pain
A study testing Passive arm elevation, Normal saline and Lidocaine in people with Propofol Injection Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to determine whether a simple technique, temporarily raising the arm during the injection of propofol (a commonly used medication for anesthesia), can reduce the pain that some people experience when the medication is given through an IV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Propofol Injection Pain
- What is being tested?
- Passive arm elevation, Normal saline and Lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- 18G or 20G dorsal hand working IV in place (drip by gravity)
- Planned IV propofol infusion with natural airway
- Able to provide consent
- Able to report pain
- English-speaking
Who cannot join
- Allergy to propofol/lidocaine
- Significant cognitive impairment/acute psychosis
- Any sedative medications given prior to the study
- Pregnancy
- Severe upper-extremity mobility limitation that prevents safe arm elevation
- Emergency medical condition; (e.g. GI bleeding, sepsis, acute heart or respiratory failure)
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- Chronic pain syndrome with chronic opioid use
- Any acute pain condition that may be distracting to the patient
- Any report of pain on gravity drip, injection of saline or spontaneous pain when testing the iv in preop prior to bringing the patient to the OR
- Pathology or prior surgery that is deemed to interfere with normal venous drainage of the arm (arterio-venous fistula, history of port or dialysis line, , history of heart failure)
- History of past or current cardiac arrhythmias, cardiac valvular abnormalities, /heart failure, stable angina that are expected to require concomitant administration of vasoactive or inotropic medications with induction
- TIA or stroke within the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Jacksonville, Florida, 32224
Mariel Anne Reyes, 904-953-4797
About this study
Official title: Efficacy of Passive Arm Elevation Versus Lidocaine Pretreatment for Prevention of Propofol Injection Pain: A Randomized, Controlled, Assessor Blinded, Pilot Feasibility Trial
The purpose of this research is to determine whether a simple technique, temporarily raising the arm during the injection of propofol (a commonly used medication for anesthesia), can reduce the pain that some people experience when the medication is given through an IV. The study will compare this technique with the current standard approach of using lidocaine (a numbing medication), as well as a combination of both methods, to determine which approach is most effective at reducing injection pain.
- Conditions
- Propofol Injection Pain
- Keywords
- propofol injection pain, propofol pain, passive arm elevation, lidocaine pretreatment,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive arm elevationProcedure or surgery
The cannulated arm is passively elevated approximately 60 to 90 degrees at the start of propofol injection and maintained briefly during and immediately after the injection before being returned to heart level.
Normal salineDrug
Normal saline 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection.
LidocaineDrug
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.
PropofolDrug
Standard LCT propofol administered as a standardized subanesthetic test dose, calculated as one-quarter of a 2.5 mg/kg induction dose using total body weight up to BMI 30 or ideal body weight above BMI 30, with a maximum study dose of 50 mg.
Sham arm elevationProcedure or surgery
The contralateral non-IV arm is elevated while the cannulated arm remains neutral.
| Study group | Role | What they receive |
|---|---|---|
| Arm Elevation Only | Experimental | Participants receive saline pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection. Receives: Procedure: Passive arm elevation; Drug: Normal saline; Drug: Propofol |
| Lidocaine Only | Active comparator | Participants receive lidocaine pretreatment followed by propofol injection while the cannulated arm remains neutral. The non-IV arm is elevated as a sham maneuver. Receives: Drug: Lidocaine; Drug: Propofol; Procedure: Sham arm elevation |
| Lidocaine Plus Arm Elevation | Experimental | Participants receive lidocaine pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection. Receives: Procedure: Passive arm elevation; Drug: Lidocaine; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Any Propofol Injection Pain
Proportion of participants reporting any propofol injection pain during or immediately after the standardized propofol test dose, defined as a verbal rating scale score of 1 or greater on a 4-point verbal rating scale where 0 indicates no pain, 1 mild pain, 2 moderate pain, and 3 severe pain.
Measured: Within approximately 30 seconds from the start of propofol injection.
Secondary outcomes (2)
Pain Severity Score
Pain severity measured as the participant's highest pain score during or immediately after the standardized propofol test dose using a 4-point verbal rating scale, where 0 indicates no pain, 1 mild pain, 2 moderate pain, and 3 severe pain.
Measured: Within approximately 30 seconds from the start of propofol injection.
Incidence of Moderate-to-Severe Propofol Injection Pain
Proportion of participants with moderate-to-severe propofol injection pain, defined as a verbal rating scale score of 2 or 3 on the 4-point verbal rating scale.
Measured: Within approximately 30 seconds from the start of propofol injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Injection PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferenc Rabai, Mayo Clinic
- Investigators
- Ferenc Rabai, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785674
- Sponsor's protocol ID
- 26-005793
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Passive Arm Elevation Versus Lidocaine Pretreatment for Prevention of Propofol Injection Pain: A Randomized, Controlled, Assessor Blinded, Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07785674
- Acronym / sponsor ID
- 26-005793
- Conditions
- Propofol Injection Pain
- Keywords
- propofol injection pain, propofol pain, passive arm elevation, lidocaine pretreatment,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Aug 2026 (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.
The purpose of this research is to determine whether a simple technique, temporarily raising the arm during the injection of propofol (a commonly used medication for anesthesia), can reduce the pain that some people experience when the medication is given through an IV. The study will compare this technique with the current standard approach of using lidocaine (a numbing medication), as well as a combination of both methods, to determine which approach is most effective at reducing injection pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Elevation Only | Experimental | Procedure: Passive arm elevation, Drug: Normal saline, Drug: PropofolParticipants receive saline pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection. |
| Lidocaine Only | Active comparator | Drug: Lidocaine, Drug: Propofol, Procedure: Sham arm elevationParticipants receive lidocaine pretreatment followed by propofol injection while the cannulated arm remains neutral. The non-IV arm is elevated as a sham maneuver. |
| Lidocaine Plus Arm Elevation | Experimental | Procedure: Passive arm elevation, Drug: Lidocaine, Drug: PropofolParticipants receive lidocaine pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA I-III
- 18G or 20G dorsal hand working IV in place (drip by gravity)
- Planned IV propofol infusion with natural airway
- Able to provide consent
- Able to report pain
Key exclusion criteria (12 listed)
- Allergy to propofol/lidocaine
- Significant cognitive impairment/acute psychosis
- Any sedative medications given prior to the study
- Pregnancy
- Severe upper-extremity mobility limitation that prevents safe arm elevation
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 |
|---|---|---|
| Passive arm elevationThe cannulated arm is passively elevated approximately 60 to 90 degrees at the start of propofol injection and maintained briefly during and immediately after the injection before being returned to heart level. | Procedure or surgery | Arm Elevation Only, Lidocaine Plus Arm Elevation |
| Normal salineNormal saline 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection. | Drug | Arm Elevation Only |
| LidocaineLidocaine 2%, 2 mL, administered intravenously before propofol injection. | Drug | Lidocaine Only, Lidocaine Plus Arm Elevation |
| PropofolStandard LCT propofol administered as a standardized subanesthetic test dose, calculated as one-quarter of a 2.5 mg/kg induction dose using total body weight up to BMI 30 or ideal body weight above BMI 30, with a maximum study dose of 50 mg. | Drug | Arm Elevation Only, Lidocaine Only, Lidocaine Plus Arm Elevation |
| Sham arm elevationThe contralateral non-IV arm is elevated while the cannulated arm remains neutral. | Procedure or surgery | Lidocaine Only |
Primary outcome
Incidence of Any Propofol Injection Pain
Time frame: Within approximately 30 seconds from the start of propofol injection.
Proportion of participants reporting any propofol injection pain during or immediately after the standardized propofol test dose, defined as a verbal rating scale score of 1 or greater on a 4-point verbal rating scale where 0 indicates no pain, 1 mild pain, 2 moderate pain, and 3 severe pain.
2 secondary outcomes
Pain Severity Score
Time frame: Within approximately 30 seconds from the start of propofol injection.
Incidence of Moderate-to-Severe Propofol Injection Pain
Time frame: Within approximately 30 seconds from the start of propofol injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Ferenc Rabai, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive arm elevation, Normal saline and Lidocaine in people with Propofol Injection Pain, run by Mayo Clinic 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 6 inclusion and 12 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariel Anne Reyes (904-953-4797, Reyes.Mariel@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Any Propofol Injection Pain (time frame: Within approximately 30 seconds from the start of propofol injection.). 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 25 Aug 2026.