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

Efficacy of Shotblocker in Spinal Needle Related Pain



Sponsors


Source

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-01-01

Completion Date

2018-09-30

Primary Completion Date

2018-08-30

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Secondary Outcome

Measure

Time Frame

Five point scale for patient satisfaction
1 minutes
Five point scale for anesthesists satisfaction
1 minutes

Enrollment

76

Conditions


Intervention

Intervention Type

Procedure

Intervention Name


Description

Patients spinal injections were performed with Shotblocker placed onto injection site

Arm Group Label

Shotblocker Group


Intervention Type

Procedure

Intervention Name


Description

Patients spinal injections were performed without Shotblocker

Arm Group Label

Placebo Group



Eligibility

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)

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

No


Location

Facility

Status

Contact

SBU Sultan Abdulhamid Han
Istanbul Asia 34668 Turkey
Recruiting
Last Name: Gökhan INANGİL
Phone: 5327739003
Email: [email protected]

Location Countries

Country

Turkey


Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Investigator Full Name

Gökhan İNANGİL

Investigator Title

Principal Investigator


Has Expanded Access

No

Number Of Arms

2

Arm Group

Arm Group Label

Shotblocker Group

Arm Group Type

Active Comparator

Description

Patients spinal injections were performed with Shotblocker placed onto injection site


Arm Group Label

Placebo Group

Arm Group Type

Placebo Comparator

Description

Patients spinal injections were performed without Shotblocker



Firstreceived Results Date

N/A

Reference

Citation

Caglar S, Büyükyılmaz F, Coşansu G, Çağlayan 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

28437308


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.

PMID

26263287


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.

PMID

19851160


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.

PMID

19497458


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.

PMID

10193230


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.

PMID

8956393



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Double (Participant, Outcomes Assessor)


Study First Submitted

May 26, 2018

Study First Submitted Qc

June 11, 2018

Study First Posted

June 12, 2018

Last Update Submitted

June 11, 2018

Last Update Submitted Qc

June 11, 2018

Last Update Posted

June 12, 2018


ClinicalTrials.gov processed this data on June 12, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP