Health TrialsbyHealthPanel

Arm Elevation for Prevention of Propofol Injection Pain

ConditionPropofol Injection Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Allergy to propofol/lidocaine

Significant cognitive impairment/acute psychosis

Any sedative medications given prior to the study

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Passive arm elevation

    Procedure/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 saline

    Drug

    Normal saline 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection.

  • Lidocaine

    Drug

    Lidocaine 2%, 2 mL, administered intravenously before propofol injection.

  • Propofol

    Drug

    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 elevation

    Procedure/Surgery

    The contralateral non-IV arm is elevated while the cannulated arm remains neutral.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Arm Elevation OnlyExperimental treatment 3 interventions
Group B: Lidocaine OnlyActive comparator 3 interventions
Group C: Lidocaine Plus Arm ElevationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Within approximately 30 seconds from the start of propofol injection.

Secondary outcomes

1

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.

Time frame
Within approximately 30 seconds from the start of propofol injection.
2

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.

Time frame
Within approximately 30 seconds from the start of propofol injection.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: