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Efficacy of Shotblocker in Spinal Needle Related Pain

The Effect of Shotblocker on Pain and Patient Satisfaction for Spinal Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03554122
Enrollment
88
Registered
2018-06-12
Start date
2018-01-01
Completion date
2018-09-30
Last updated
2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Needle Phobia, Pain, Spinal Anesthesia

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.

Interventions

PROCEDUREShotblocker

Patients spinal injections were performed with Shotblocker placed onto injection site

PROCEDUREPlacebo

Patients spinal injections were performed without Shotblocker

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)2 minutesAssessment 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

MeasureTime frameDescription
Five point scale for patient satisfaction1 minutes5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant
Five point scale for anesthesists satisfaction1 minutes5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026