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Completed

NCT Number: NCT03554122

Efficacy of Shotblocker in Spinal Needle Related Pain

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.

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Key information

Conditions

Needle Phobia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU Sultan Abdulhamid Han

Istanbul, Asia, 34668, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Shotblocker

Procedure

Patients spinal injections were performed with Shotblocker placed onto injection site

Placebo

Procedure

Patients spinal injections were performed without Shotblocker

Primary outcomes

  1. 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

  1. Five point scale for patient satisfaction

    Time frame: 1 minutes

    5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant

  2. Five point scale for anesthesists satisfaction

    Time frame: 1 minutes

    5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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