NCT05208632

Brief Summary

Abstract: Background: In investigators study, we aimed to compare PI and PVI between the interscalen block and infraclavicular block and evaluate its use as an early marker in block success. Meterial- Methods: 40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

December 13, 2021

Last Update Submit

January 13, 2022

Conditions

Perfusion Index and Pleth Variability Index an Early Indicator of the Success of Brachial Plexus Block; Randomized Clinical Trial

Keywords

brachial plexusinterscalene blockinfraclavicular blockPerfusion indexPleth Variability Indexregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Perfusion index: PI

    monitoring, both upper extremities Perfusion index: PI, (The probe of a MasimoRadical 7, MasimoCorp. Irvine, CA, USA) were performed.

    10 WEEK

Secondary Outcomes (1)

  • Plethysmographic variability index: PVI

    10 WEEK

Other Outcomes (1)

  • hemoglobin HGB,

    10 WEEK

Study Arms (2)

BLOCK SİDE

40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Other: INTERSCALEN BLOCK APPLICATION WITH USG

UNBLOCK SİDE

40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Other: INTERSCALEN BLOCK APPLICATION WITH USG

Interventions

INTERSCALEN BLOCK APPLICATION WITH USGOTHER

40 patients, including ASA1-2, 20 patients over the age of 18, who were planned for upper extremity surgery, in the interscalen group, and 20 in the supraclavicular group, were included in the study. Demographic data of the patients were recorded by measuring PI and PVI values at baseline before the block and at the 1st, 5th, 10th, 15th, and 20th minutes after the block, both simultaneously.

Also known as: SHOULDER SURGERY
BLOCK SİDEUNBLOCK SİDE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who will undergo upper-term surgery

You may qualify if:

  • ASA classification (American Society of Anesthesiologists) I-II score
  • no contraindications for block
  • patient's acceptance

You may not qualify if:

  • Pediatric patients
  • pregnant patients
  • patients with peripheral arterial disease
  • renal failure
  • liver failure
  • coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Eğitim Ve Araştirma Hastanesi

Malatya, 44100, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ANESTHESIOLOGY AND REANIMATION CLINIC

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 26, 2022

Study Start

January 1, 2021

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)