The Effect of Different Types of Spinal Needles on the Success of the Procedure

The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study

The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling.

Study Overview

• Status: Completed
• Conditions: Spinal Needle Diameter and Design, Click Feeling
• Intervention / Treatment: Other: Spinal anesthesia application

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey, 67600
    • Gamze Küçükosman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

213

Description

Inclusion Criteria:

• Elective lower abdomen/extremity surgery planned,
• American Society of Anesthesiologists (ASA) I-II risk group,
• without bleeding diathesis
• patients with written consent

Exclusion Criteria:

• Patients for whom spinal anesthesia is contraindicated,
• morbidly obese,
• pregnant
• Patients with a history of allergic reactions to the drugs used in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quincke (Q)-25 Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Quincke (Q)-26Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Quincke (Q)-27 Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Pencil-point (P)-25Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Pencil-point (P)-26Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application
Pencil-point (P)-27Gauge	Other: Spinal anesthesia application; The success of the needles with different tip designs and thicknesses used in spinal anesthesia application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study	Clicking feeling: Considering that the click feeling due to dural puncture is taken, in which attempt (1, 2, and ≥3) the needle's guide was removed and the cerebrospinal fluid (CSF) arrival occurred Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)	Spinal anesthesia procedure time
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study	Procedural success: Time until CSF is seen (<1.9sec, ≥2sec)	Spinal anesthesia procedure time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study	First-year anesthesia assistants get a click feeling with needles with different tip designs and diameters	Spinal anesthesia procedure time

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2018/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No