Efficacy of Shotblocker in Spinal Needle Related Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554122
• Other study ID #: SultanAbdulhamid
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2019
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Needle Phobia
• Pain
• Spinal Anesthesia

Intervention

Procedure:
• Shotblocker
Patients spinal injections were performed with Shotblocker placed onto injection site
• Placebo
Patients spinal injections were performed without Shotblocker

Locations

Country	Name	City	State
Turkey	SBU Sultan Abdulhamid Han	Istanbul	Asia

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Caglar S, Büyükyilmaz F, Cosansu G, Çaglayan 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. — View Citation

Çelik 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. — View Citation

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. — View Citation

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. — View Citation

Koscielniak-Nielsen Z, Hesselbjerg L, Brushøj 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Five point scale for patient satisfaction	5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant	1 minutes
Secondary	Five point scale for anesthesists satisfaction	5 very good, 4 good, 3 satisfactory, 2 unpleasant, 1 very unpleasant	1 minutes