NCT05706090

Brief Summary

The need of a neurostimulator for a successful nerve block was questioned in different block types after ultrasound has become standard. The aim of this clinical study was to determine the effect of neurostimulator use on block success in costoclavicular block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

December 20, 2022

Last Update Submit

January 20, 2023

Conditions

PATIENTS WITH UPPER EXTREMITY SURGERY

Keywords

Brachial Plexus Block; Nerve Block; Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • The block success rate (ratio of successful blocks to all blocks)

    The block was considered unsuccessful in case of analgesic need during the surgery or transition to general anesthesia, otherwise, these patients were included in the successful block group.

    during procedure

Secondary Outcomes (3)

  • Block application time

    30 minutes

  • time to readiness for surgery

    30 minutes

  • number of needle passes

    30 minutes

Study Arms (2)

Group USP

EXPERIMENTAL

The group using ultrasound and injection pressure manometer was named USP

Drug: fentanyl will be addedProcedure: general anesthesia

Group USPN

EXPERIMENTAL

The group using ultrasound , injection pressure manometer , and neurostimulator was named USPN

Drug: fentanyl will be addedProcedure: general anesthesia

Interventions

fentanyl will be addedDRUG

If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added

Group USPGroup USPN
general anesthesiaPROCEDURE

If adequate anagesia is not provided with the block, general anesthesia will be administered.

Group USPGroup USPN

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Class I, II and III of American Society of Anesthesiologists (ASA) classification
  • being between 18 and 80 years of age,
  • body mass index (BMI) between 18 and 35 kg/m2

You may not qualify if:

  • Patients who did not give consent,
  • were above ASA III,
  • pregnant,
  • had a neuromuscular disease,
  • bleeding diathesis,
  • a local anesthetic allergy,
  • an infection in the area where nerve block would be applied, and
  • had previously operated from the infraclavicular fossa were not included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazoosmanpasa Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 31, 2023

Study Start

February 1, 2020

Primary Completion

February 1, 2020

Study Completion

January 2, 2021

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)