The Effect of Shotblocker on Pain and Patient Satisfaction for Spinal Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)
Study Overview
Brief Summary
This was a single-blind, randomized controlled trial. Seventy-six patients who underwent spinal anesthesia for surgery were randomized into the Shotblocker group or Control group. Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the pain intensity of spinal needle insertion and a five-point scale for patient satisfaction were compared between the two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing surgery
Exclusion Criteria
- •contraindications to regional anesthesia
- •refusal of the patient's regional anesthesia
- •intellectual disabilities that prevented completion of a visual analog scale (VAS)
Arms & Interventions
Shotblocker Group
Patients spinal injections were performed with Shotblocker placed onto injection site
Intervention: Shotblocker (Procedure)
Placebo Group
Patients spinal injections were performed without Shotblocker
Intervention: Placebo (Procedure)
Outcomes
Primary Outcomes
Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)
Time Frame: 2 minutes
Assessment of pain during spinal needle insertion will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured
Secondary Outcomes
- Five point scale for anesthesists satisfaction(1 minutes)
- Five point scale for patient satisfaction(1 minutes)
Investigators
Gökhan İNANGİL
Principal Investigator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey