Efficacy of Shotblocker in Spinal Needle Related Pain

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Pain; Needle Phobia
• Interventions: Procedure: Placebo; Procedure: Shotblocker

• 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

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Patients spinal injections were performed without Shotblocker
Shotblocker Group	Shotblocker	Patients spinal injections were performed with Shotblocker placed onto injection site

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