Arm Elevation for Prevention of Propofol Injection Pain

August 21, 2026 updated by: Ferenc Rabai, Mayo Clinic

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
        • Contact:
          • Mariel Anne Reyes
          • Phone Number: 904-953-4797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm Elevation Only
Participants receive saline pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection.
Procedure: Passive arm elevation
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.
Drug: Normal saline
Normal saline 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection.
Drug: Propofol
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.
Active Comparator: Lidocaine Only
Participants receive lidocaine pretreatment followed by propofol injection while the cannulated arm remains neutral. The non-IV arm is elevated as a sham maneuver.
Drug: Propofol
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.
Drug: Lidocaine
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.
Procedure: Sham arm elevation
The contralateral non-IV arm is elevated while the cannulated arm remains neutral.
Experimental: Lidocaine Plus Arm Elevation
Participants receive lidocaine pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection.
Procedure: Passive arm elevation
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.
Drug: Propofol
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.
Drug: Lidocaine
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within approximately 30 seconds from the start of propofol injection.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Severity Score
Time Frame: Within approximately 30 seconds from the start of propofol injection.
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.
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.
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.
Within approximately 30 seconds from the start of propofol injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ferenc Rabai, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-005793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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