Vibration-Assisted Anaesthesia: A Randomised Controlled Trial to Investigate Whether Vibration Reduces the Pain of Anaesthetic Injection in Eyelid Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.
Study Overview
Brief Summary
Aim of study is to investigate whether a small, non-invasive vibrating device applied to the forehead during local anaesthetic administration reduces the pain of the injection.
Detailed Description
Purpose:
To carry out a prospective randomised controlled clinical trial to compare the efficacy of vibration in reducing the pain of local anaesthetic injections into the upper eyelid.
Hypothesis:
Vibration of the adjacent soft tissue reduces the pain of anaesthetic injections in upper eyelid surgery.
Justification:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult patients (> 16 years) undergoing bilateral upper eyelid surgery under local anaesthetic who have given fully informed consent to be in the trial
Exclusion Criteria
- •Age less than 16 years
- •Previous upper eyelid surgery
Arms & Interventions
1
Group receiving vibration-assisted anaesthesia
Intervention: Vibration-assisted anaesthesia (Procedure)
2
Group receiving switched-off vibrating device
Intervention: Switched-off vibrating device (Procedure)
Outcomes
Primary Outcomes
Patients' verbal pain scores will be elicited and documented immediately by the oculoplastic fellow.
Time Frame: Immediately
Secondary Outcomes
No secondary outcomes reported