ClinicalTrials.Veeva

Menu

Vibration Analgesia in Propofol Infusion During Anesthesia Induction (VAPI)

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status

Completed

Conditions

Pain, Acute

Treatments

Device: BUZZY(tm)
Other: No Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03509857
2017-8323

Details and patient eligibility

About

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Full description

Background and Significance Infusion of propofol during the process of inducing anesthesia can cause a fair amount of transient discomfort to patients while the are on the operating table and of intact faculties. It is not uncommon for patients to cry out in pain. The investigators have noticed this first hand on numerous occasions and have wondered if there is a risk-free way to lesson the pain associated with propofol infusion.

This study will focus on the use of vibration analgesia to potentially reduce the pain associated with propofol infusion. Vibration is proposed to stimulate A-beta nerve fibers, which transmit information from vibration and touch which, according to the Gate Control Theory of Pain (Melzack and Wall 1965), inhibits signal transduction by A-delta and C fibers (Kakigi and Shibasaki 1992). Vibration has been demonstrated to be effective to decrease pain during vaccinations, phlebotomy, and dental anesthesia (Baxter et al. 2011; Nanitsos et al. 2009).

In this study, the investigators seek to evaluate the role of vibration in the reduction of discomfort associated with painful stimulus associated with anesthesia induction. Through this study, the investigators hope to develop a comprehensive and cost-effective approach to minimize patient discomfort during anesthesia induction.

Study Design

The objective of this study is to evaluate the effectiveness of vibration as a analgesic during induction of anesthesia. It is the investigators hypothesis that both vibration will lessen the pain of propofol infusion.

Patients set to receive a propofol infusion as part of induction of anesthesia during surgery will be recruited to participate in this study. All participating patients will be randomized following acquisition of consent for study participation to one of two intervention groups: 1) normal standard of care infusion of propofol without analgesia 2) infusion of propofol with application of vibration analgesia. Patients will then be asked to place a mark on a 100-mm visual analogue scale corresponding to the level of pain that they experienced during the digital block. Additionally, Please see the next section for specific details regarding the intervention.

Due to constraints regarding the validity of the linear visual analogue scale in very young patients (Stinson et al. 2006), only those aged 18 years or older will be eligible for participation in the study. Parents or guardians will provide consent for minors or for individuals who are otherwise unable to provide consent themselves.

Enrollment

100 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery

Exclusion criteria

  • Those below the age of 18

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

normal standard of care infusion of propofol without analgesia
Placebo Comparator group
Description:
normal standard of care infusion of propofol without analgesia
Treatment:
Other: No Intervention
infusion of propofol with application of vibration analgesia
Experimental group
Description:
infusion of propofol with application of vibration analgesia
Treatment:
Device: BUZZY(tm)

Trial documents
3

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems