Arm Elevation for Prevention of Propofol Injection Pain
21. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
45
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mariel Anne Reyes
- Telefonnummer: 904-953-4797
- E-post: Reyes.Mariel@mayo.edu
Studer Kontakt Backup
- Navn: Ally Sapin
- Telefonnummer: 904-953-7929
- E-post: Sapin.Alyssa@mayo.edu
Studiesteder
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic
-
Ta kontakt med:
- Mariel Anne Reyes
- Telefonnummer: 904-953-4797
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm Elevation Only
Participants receive saline pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection.
|
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 0.9%, 2 mL, administered intravenously as sham lidocaine before propofol injection.
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.
|
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Aktiv komparator: 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.
|
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.
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.
The contralateral non-IV arm is elevated while the cannulated arm remains neutral.
|
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Eksperimentell: Lidocaine Plus Arm Elevation
Participants receive lidocaine pretreatment followed by propofol injection with passive elevation of the cannulated arm during propofol injection.
|
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.
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.
Lidocaine 2%, 2 mL, administered intravenously before propofol injection.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Any Propofol Injection Pain
Tidsramme: Within approximately 30 seconds from the start of propofol injection.
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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.
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Within approximately 30 seconds from the start of propofol injection.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Severity Score
Tidsramme: Within approximately 30 seconds from the start of propofol injection.
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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.
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Within approximately 30 seconds from the start of propofol injection.
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Incidence of Moderate-to-Severe Propofol Injection Pain
Tidsramme: Within approximately 30 seconds from the start of propofol injection.
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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.
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Within approximately 30 seconds from the start of propofol injection.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ferenc Rabai, MD, Mayo Clinic
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
21. august 2026
Først innsendt som oppfylte QC-kriteriene
21. august 2026
Først lagt ut (Faktiske)
25. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-005793
Plan for individuelle deltakerdata (IPD)
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produkt produsert i og eksportert fra USA
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