Efficacy of Shotblocker in Spinal Needle Related Pain

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status: Completed

Conditions: Needle Phobia; Spinal Anesthesia; Pain

Treatments: Procedure: Shotblocker; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03554122

SultanAbdulhamid

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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88 participants in 2 patient groups, including a placebo group

Shotblocker Group

Active Comparator group

Description:

Patients spinal injections were performed with Shotblocker placed onto injection site

Treatment:

Procedure: Shotblocker

Placebo Group

Placebo Comparator group

Description:

Patients spinal injections were performed without Shotblocker

Treatment:

Procedure: Placebo