Efficacy of Virtual Reality Distraction Technique for Anxiety and Pain Control in Orthopedic Forearm Surgeries Performed Under Supraclavicular Brachial Plexus Block
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- ● To estimate amount of IV sedation needed for the patient
Study Overview
Brief Summary
Invistigators hypothesized that using of VR distraction technique during performing peripheral regional anesthesia (supraclavicular block) would lead to better perioperative analgesia and less anxiety.
Detailed Description
Methodology I. Study design This is a controlled randomized prospective study. II. Study setting and location The study will be conducted at Cairo University Hospital - orthopedic surgery unit.
III. Study population Participants will be adult patients (above 18 years), ASA I-II, scheduled for elective forearm orthopedic surgeries under ultrasound guided supraclavicular approach for brachial plexus block.
IV. Study Procedures
- Randomization Patients will be randomly allocated by a computer-generated table into one of the study groups; the randomization sequence will be concealed in sealed envelopes. Patients and data collector will be blind to group assignment.
- Study Protocol Following approval from Ethics and Research Committee of Anesthesia Department, Faculty of Medicine, Cairo University, All patients will be subjected to systematic preoperative assessment including history taking, physical examination, and review of the results of routine investigations.
Upon arrival to the preparation room: A 20 gauge IV cannula is inserted into a peripheral vein then patients will be transferred to the operating room where basic monitoring Electrocardiography (ECG), Non-invasive Blood Pressure (NIBP) and pulse oximetry are attached. Baseline heart rate, blood pressure, oxygen saturation and respiratory rate will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA physical status I-II. patients scheduled for elective forearm orthopedic surgeries under ultrasound guided supraclavicular approach for brachial plexus block with good mental function.
Exclusion Criteria
- •Patient's refusal.
- •Known allergy to local anesthetics.
- •Bleeding disorders, Use of any anti-coagulants.
- •Inability to provide informed consent.
- •Patient with psychiatric disorders.
- •Sensory impairment (blindness, deafness).
- •Any technical problem preventing proper fitting of the glasses to the patient face
- •patients with cognitive impairment, epilepsy or with claustrophobia
- •patients with suspected eye infection
Arms & Interventions
midazolam group
Intervention: Midazolam (Drug)
VR group
Intervention: VR (Device)
Outcomes
Primary Outcomes
● To estimate amount of IV sedation needed for the patient
Time Frame: (time from block needle entry till the end of the procedure)
Secondary Outcomes
No secondary outcomes reported
Investigators
Haitham Hassan Eltrabily
lecturer of anasthesia and pain management
Cairo University