Arm Elevation for Prevention of Propofol Injection Pain

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: Not yet recruiting
• Conditions: Propofol Injection Pain
• Intervention / Treatment: Procedure: Passive arm elevation; Drug: Normal saline; Drug: Propofol; Drug: Lidocaine; Procedure: Sham arm elevation

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariel Anne Reyes; Phone Number: 904-953-4797; Email: Reyes.Mariel@mayo.edu
• Study Contact Backup: Name: Ally Sapin; Phone Number: 904-953-7929; Email: Sapin.Alyssa@mayo.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Within approximately 30 seconds from the start of propofol injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within approximately 30 seconds from the start of propofol injection.

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ferenc Rabai, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 21, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: propofol injection pain, propofol pain, passive arm elevation, lidocaine pretreatment,
• Additional Relevant MeSH Terms: Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Phenols; Benzene Derivatives; Crystalloid Solutions; Isotonic Solutions; Solutions; Lidocaine; Propofol; Saline Solution
• Other Study ID 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