Vibration Anesthesia for Propofol- Rocuronium Injection Pain

Pain Due to Certain Specified Procedures Clinical Trial

Official title:

Vibration Anesthesia for Propofol- Rocuronium Injection Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987866
• Other study ID #: E1-21-1740
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Due to Certain Specified Procedures
• Vibration

Intervention

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)

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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