Vibration Anesthesia for Propofol- Rocuronium Injection Pain

Despite numerous strategies for preventing or alleviating pain associated with propofol and rocuronium injections, it remains common and distressing for patients. Vibration is an effective method of reducing pain during facial cosmetic injections and some venipuncture procedures. But it has not been previously studied in the context of propofol or rocuronium injection pain. This randomized study aims to evaluate the effect of vibration anesthesia on the incidence and severity of propofol and rocuronium injection pain.

Study Overview

• Status: Completed
• Conditions: Pain Due to Certain Specified Procedures; Vibration
• Intervention / Treatment: Device: vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China

Detailed Description

Due to their rapid onset and short duration of action, ease of titration, recovery, and favorable profile for side effects, propofol and rocuronium are agents frequently used together in anesthesia practice and for rapid-sequence intubation. However, both cause severe discomfort due to pain in the injection arm. Some patients recall the induction of anesthesia as the most painful part of the perioperative period.

Vibration anesthesia has repeatedly been shown to alleviate pain sensation effectively and safely. Vibration anesthesia device is designed to reduce the pain from minor procedures, such as injection of medications, suture or staple removal, phlebotomy and even venipuncture pain in pediatric patients. The advantages of this device include its low cost, lack of adverse effects, and ease of use.

It has been shown to reduce pain with a mechanism based on the gate control theory, which states that vibrations stimulate the dorsal horn neurons, the sites at which pain signals are modulated and thus block full transmission of the pain.The investigators therefore proposed this randomized controlled study to compare the effectiveness of a vibration device for propofol and rocuronium injection pain during general anesthesia induction.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I-II patients
• Patients who are planned to undergo gynecology operations

Exclusion Criteria:

• Participants who were pregnant,
• Patients who had a recent history of a severe allergic or hypersensitivity reaction to propofol or rocuronium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group Vibration; The participants who were chose an opaque envelope containing yellow paper represented the vibration group (Group V). After 1 min of pre-treatment with the vibration device on the intravenous catheter trace, we manually injected 2-2,5 mg/kg, 1% propofol (Propofol 1%, Fresenius 20 ml flacon, Germany) over 15 s. Observer rated the pain responses according to a four-point scale which developed by McCrirrick and Hunterand. Also asked the patients whether they had any discomfort. After the propofol injection, pain scores were observed during propofol injection and 20 seconds after the injection, and hemodynamic records were taken. 0,6 mg/kg rocuronium (Esmeron® 50 mg.5ml-1 N.V. Organon, Oss, Holland) were injected over 10 seconds. The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS) during and after 20 seconds rocuronium injection.	Device: vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China; The vibration device is a reusable, handheld device with a battery-powered motor and a vibration frequency of approximately 6000 times per minute (Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China)
NO_INTERVENTION: group Control; The participants who were chose an opaque envelope containing red paper represented the group control (Group C).Only propofol and rocuronium were given to these patients. propofol injection made manually 2-2,5 mg/kg, 1% propofol (Propofol 1%, Fresenius 20 ml flacon, Germany) over 15 s. Patients were observed during and after the injection of propofol for 20 seconds. Observer rated the pain responses according to a four-point scale which developed by McCrirrick and Hunter. During the injection of propofol, we also asked the patients whether they had any discomfort. After the propofol injection for 20 seconds, pain scores were observed, and hemodynamic records were taken. 0,6 mg/kg rocuronium (Esmeron® 50 mg.5ml-1 N.V. Organon, Oss, Holland) were injected over 10 seconds. The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS) during and 20 seconds after the rocuronium injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preventing or reducing propofol injection pain	Observer rated the pain responses according to a four-point scale. After the injection of propofol to, we also asked the patients whether they had any discomfort.The severity of propofol- injection was evaluated using the following four-point pain response scale developed by McCrirrick and Hunter: level 0: (no pain) no verbal/ facial/ motor reaction to the injection; level 1: (mild pain) a minor verbal/ facial/ motor reaction to the injection but no physical activity or wrist joint movements; and level 2: (moderate pain), pain when asked by the anesthesiologist, or complaint of pain during the injection accompanied by physical activity- facial grimacing or withdrawal of the arm (elbow-shoulder); and level 3: (sever pain), a response accompanied by a facial expression of pain, or a strong vocal response, tears, arm withdrawal, and full body reaction ( including other body movements)	patients were observed during and after the injection of propofol for 20 seconds by an observer
preventing or reducing rocuronium injection pain	The movement response to rocuronium injection pain was evaluated by the same observer on a four-point scale (FPS). The scale was 0: no movement, 1: movement only the wrist, 2: movement of only the arm (elbow-shoulder) and, 3: general response, movement more than one extremity. 2 minutes after induction, intubation was completed.	patients were observed during and after the injection of rocuronium for 20 seconds by an observer

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (ACTUAL): August 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: analgesia; vibration; propofol injection pain; rocuronium injection pain
• Other Study ID Numbers: E1-21-1740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No