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Efficacy of Shotblocker in Spinal Needle Related Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554122
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gökhan İNANGİL, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description
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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.

Condition or disease Intervention/treatment Phase
Needle Phobia Spinal Anesthesia Pain Procedure: Shotblocker Procedure: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Shotblocker on Pain and Patient Satisfaction for Spinal Anesthesia
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554122


Locations
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Turkey
SBU Sultan Abdulhamid Han
Istanbul, Asia, Turkey, 34668
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
More Information
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Publications:

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Responsible Party: Gökhan İNANGİL, Principal Investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT03554122    
Other Study ID Numbers: SultanAbdulhamid
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No