Efficacy of Shotblocker in Spinal Needle Related Pain

October 24, 2019 updated by: Gökhan İNANGİL, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Asia
      • Istanbul, Asia, Turkey, 34668
        • SBU Sultan Abdulhamid Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Shotblocker Group
Patients spinal injections were performed with Shotblocker placed onto injection site
Procedure: Shotblocker
Patients spinal injections were performed with Shotblocker placed onto injection site
PLACEBO_COMPARATOR: Placebo Group
Patients spinal injections were performed without Shotblocker
Procedure: Placebo
Patients spinal injections were performed without Shotblocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five point scale for patient satisfaction
Time Frame: 1 minutes
5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant
1 minutes
Five point scale for anesthesists satisfaction
Time Frame: 1 minutes
5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant
1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

August 30, 2018

Study Completion (ACTUAL)

September 30, 2018

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (ACTUAL)

June 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SultanAbdulhamid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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