NCT03554122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

8 months

First QC Date

May 26, 2018

Last Update Submit

October 24, 2019

Conditions

Needle PhobiaSpinal AnesthesiaPain

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain during spinal needle insertion with 10 cm VAS (Visual Analog Scale)

    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 Outcomes (2)

  • Five point scale for patient satisfaction

    1 minutes

  • Five point scale for anesthesists satisfaction

    1 minutes

Study Arms (2)

Shotblocker Group

ACTIVE COMPARATOR

Patients spinal injections were performed with Shotblocker placed onto injection site

Procedure: Shotblocker

Placebo Group

PLACEBO COMPARATOR

Patients spinal injections were performed without Shotblocker

Procedure: Placebo

Interventions

ShotblockerPROCEDURE

Patients spinal injections were performed with Shotblocker placed onto injection site

Shotblocker Group
PlaceboPROCEDURE

Patients spinal injections were performed without Shotblocker

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery

You may not qualify if:

  • contraindications to regional anesthesia
  • refusal of the patient's regional anesthesia
  • intellectual disabilities that prevented completion of a visual analog scale (VAS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Sultan Abdulhamid Han

Istanbul, Asia, 34668, Turkey (Türkiye)

Location

Related Publications (6)

  • Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.

    PMID: 28437308BACKGROUND

  • Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105.

    PMID: 26263287BACKGROUND

  • Cobb JE, Cohen LL. A randomized controlled trial of the ShotBlocker for children's immunization distress. Clin J Pain. 2009 Nov-Dec;25(9):790-6. doi: 10.1097/AJP.0b013e3181af1324.

    PMID: 19851160BACKGROUND

  • Drago LA, Singh SB, Douglass-Bright A, Yiadom MY, Baumann BM. Efficacy of ShotBlocker in reducing pediatric pain associated with intramuscular injections. Am J Emerg Med. 2009 Jun;27(5):536-43. doi: 10.1016/j.ajem.2008.04.011.

    PMID: 19497458BACKGROUND

  • Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x.

    PMID: 10193230BACKGROUND

  • Sharma SK, Gajraj NM, Sidawi JE, Lowe K. EMLA cream effectively reduces the pain of spinal needle insertion. Reg Anesth. 1996 Nov-Dec;21(6):561-4.

    PMID: 8956393BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2018

First Posted

June 12, 2018

Study Start

January 1, 2018

Primary Completion

August 30, 2018

Study Completion

September 30, 2018

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

TU(1)