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Vibration Analgesia in Propofol Infusion During Anesthesia Induction (VAPI)

Primary Purpose

Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BUZZY(tm)
No Intervention
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Pain, Acute pain, Analgesia, Propofol infusion

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Montefiore Hutchinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

normal standard of care infusion of propofol without analgesia

infusion of propofol with application of vibration analgesia

Arm Description

normal standard of care infusion of propofol without analgesia

infusion of propofol with application of vibration analgesia

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 4, 2018
Last Updated
September 9, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03509857
Brief Title
Vibration Analgesia in Propofol Infusion During Anesthesia Induction
Acronym
VAPI
Official Title
Vibration Analgesia in Propofol Infusion During Anesthesia Induction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
Pain, Acute pain, Analgesia, Propofol infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal standard of care infusion of propofol without analgesia
Arm Type
Placebo Comparator
Arm Description
normal standard of care infusion of propofol without analgesia
Arm Title
infusion of propofol with application of vibration analgesia
Arm Type
Experimental
Arm Description
infusion of propofol with application of vibration analgesia
Intervention Type
Device
Intervention Name(s)
BUZZY(tm)
Intervention Description
Risks associated with the BUZZY(tm) device The intervention group will receive vibration only, with application of the BUZZY device just proximal to the intravenous infusion site immediately before and during propofol infusion. There are no known risks for the use of the BUZZY(tm) device, which is registered as an FDA class III device ("therapeutic massager").
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct
Description
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.
Time Frame
Day 1 at time of propofol injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aravind Pothula
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Hutchinson Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22134226
Citation
Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.
Results Reference
background
PubMed Identifier
6203084
Citation
Bini G, Cruccu G, Hagbarth KE, Schady W, Torebjork E. Analgesic effect of vibration and cooling on pain induced by intraneural electrical stimulation. Pain. 1984 Mar;18(3):239-248. doi: 10.1016/0304-3959(84)90819-4.
Results Reference
background
PubMed Identifier
23283255
Citation
Depue K, Christopher NC, Raed M, Forbes ML, Besunder J, Reed MD. Efficacy of intravenous lidocaine to reduce pain and distress associated with propofol infusion in pediatric patients during procedural sedation. Pediatr Emerg Care. 2013 Jan;29(1):13-6. doi: 10.1097/PEC.0b013e31827b227e.
Results Reference
background
PubMed Identifier
11952433
Citation
Grauers A, Liljeroth E, Akeson J. Propofol infusion rate does not affect local pain on injection. Acta Anaesthesiol Scand. 2002 Apr;46(4):361-3. doi: 10.1034/j.1399-6576.2002.460405.x.
Results Reference
background
PubMed Identifier
1583512
Citation
Kakigi R, Shibasaki H. Mechanisms of pain relief by vibration and movement. J Neurol Neurosurg Psychiatry. 1992 Apr;55(4):282-6. doi: 10.1136/jnnp.55.4.282.
Results Reference
background
PubMed Identifier
18006530
Citation
Lee JR, Jung CW, Lee YH. Reduction of pain during induction with target-controlled propofol and remifentanil. Br J Anaesth. 2007 Dec;99(6):876-80. doi: 10.1093/bja/aem293.
Results Reference
background
PubMed Identifier
5320816
Citation
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
Results Reference
background
PubMed Identifier
19473149
Citation
Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.
Results Reference
background
PubMed Identifier
16777328
Citation
Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.
Results Reference
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Vibration Analgesia in Propofol Infusion During Anesthesia Induction

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