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Clinical Trials/NCT03509857
NCT03509857CompletedNot Applicable

Vibration Analgesia in Propofol Infusion During Anesthesia Induction

Montefiore Medical Center2 sites in 1 country100 target enrollmentStarted: February 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct

Time Frame: Day 1 at time of propofol injection

Patient pain will be assessed by two independent observers, an attending anesthesiologist and a certified registered nurse anesthetist (CRNA). Pain was graded using a four-point pain manifestation scale described by McCrirrick \& Hunter : 0 = none (negative response to questioning), 1 = mild (pain reported in response to questioning only, without any behavioral signs), 2 = moderate (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning), 3 = severe (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears). Higher scores meaning worse outcome (perceived pain) and lower score meaning better outcome.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aravind Pothula

Principal investigator

Montefiore Medical Center

Study Sites (2)

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