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.
Brief Title
Vibration Analgesia in Propofol Infusion 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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Pain, Acute
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery
* Those aged 18 to 100 who are going to receive propofol injection as part of induction of anesthesia for surgery
Gender
All
Gender Based
false
Keywords
Pain
Acute pain
Analgesia
Propofol infusion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
18 Years
NCT Id
NCT03509857
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8323
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Vibration Analgesia in Propofol Infusion During Anesthesia Induction
Primary Outcomes
Outcome 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.
Outcome Measure
Level of Pain as Observed by Two Independent Observers Following Propofol Injection, With or Without a Vibration Analgesia Adjunct
Outcome Time Frame
Day 1 at time of propofol injection
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aravind Pothula
Investigator Email
apothula@montefiore.org
Investigator Phone