Efficacy of Shotblocker in Spinal Needle Related Pain

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Pain; Needle Phobia

• Registration Number: NCT03554122
• Lead Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Primary Completion: 2018-08-30
• Study Completion: 2018-09-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)	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 Outcome Measures

Name	Time	Method
Five point scale for anesthesists satisfaction	1 minutes	5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant
Five point scale for patient satisfaction	1 minutes	5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant

Trial Locations

Locations (1)

SBU Sultan Abdulhamid Han; 🇹🇷 Istanbul, Asia, Turkey