Efficacy of Shotblocker in Spinal Needle Related Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Needle Phobia Spinal Anesthesia Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Shotblocker Group

Patients spinal injections were performed with Shotblocker placed onto injection site

Group Type ACTIVE_COMPARATOR

Shotblocker

Intervention Type PROCEDURE

Patients spinal injections were performed with Shotblocker placed onto injection site

Placebo Group

Patients spinal injections were performed without Shotblocker

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Patients spinal injections were performed without Shotblocker

Interventions

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Shotblocker

Patients spinal injections were performed with Shotblocker placed onto injection site

Intervention Type PROCEDURE

Placebo

Patients spinal injections were performed without Shotblocker

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No