Predictive Value Of Muscle Tone And Perfusion Index In Supraclavicular Block Success.

NCT ID: NCT06915519

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-31

Brief Summary

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The goal of this observational study is to define the usefulness of a new device to predict the supraclavicular block successfulness in the patients scheduled to orthopedic surgery. The main question it aims to answer is:

¿The combination between a flexometer and perfusion index is capable to predict the successfulness of a supraclavicular block in the first 15 min?

Participants will be anesthetized by residents or anesthesiologist with regional anesthesia training and then connected to a flexometer to measure the motor blockade and a pulse oximeter to measure the perfusion index related to sympathetic blockage at 0, 5, 10 and 15 min .

Detailed Description

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Prospective observational pilot study conducted at "Dr. Ignacio Morones Prieto" Central Hospital, Mexico, involving 33 patients (ASA 1, 2, 3) requiring surgery on the distal third of the upper limb with ultrasound-guided SCPB. The motor block was assessed with a conductive ink flexion sensor, and the sympathetic block was evaluated with perfusion index via pulse oximeter at 3, 5, 10, and 15 minutes. Block success was defined as a Numerical Rating Scale (NRS) for pain \<2 during surgical stimulation. Statistical comparisons were made between successful and unsuccessful blocks, with ROC curve analysis identifying optimal cutoff points for predictive variables.

Conditions

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Regional Anesthesia Success Orthopedic Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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measure motor strength and perfusion index

measurements of the motor strength and perfusion index in the blocked hand to predict the successfulness of the supraclavicular block at 0, 5, 10 and 15 min post blockage.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with 18 years and older.
* ASA 1, 2, and 3.
* patients who required surgical intervention in the distal two-thirds of an upper limb and warranted the application of an ultrasound-guided supraclavicular brachial plexus block.

Exclusion Criteria

* infection at the puncture site
* allergy to local anesthetics
* diagnosis of coagulopathy
* restrictive pulmonary pathology
* diaphragmatic pathology
* dependence on supplemental oxygen
* brachial plexus radiculopathy
* uncontrolled type 2 diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role lead

Responsible Party

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Gloria Fabiola Alvarez-Orenday

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco A Govea-Hernandez, Anesthesiologist

Role: STUDY_DIRECTOR

anesthesia department

Mauricio Guerra-Hernandez, Medical Doctor

Role: STUDY_CHAIR

Anesthesiology Departmen

Venance Basil-Kway, Medical Doctor

Role: STUDY_DIRECTOR

Clinical Investigation Department

Locations

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Hospital General "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

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Mexico

References

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Roy M, Nadeau MJ, Cote D, Levesque S, Dion N, Nicole PC, Turgeon AF. Comparison of a single- or double-injection technique for ultrasound-guided supraclavicular block: a prospective, randomized, blinded controlled study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):55-9. doi: 10.1097/AAP.0b013e3182367b97.

Reference Type BACKGROUND
PMID: 22030724 (View on PubMed)

Perlas A, Lobo G, Lo N, Brull R, Chan VW, Karkhanis R. Ultrasound-guided supraclavicular block: outcome of 510 consecutive cases. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):171-6. doi: 10.1097/AAP.0b013e31819a3f81.

Reference Type BACKGROUND
PMID: 19282715 (View on PubMed)

Vásquez, M., Jiménez, A., Aguirre, O., Gonzalez, M., y Ríos, A. (2012). Bilateral ultrasound-guided supraclavicular block. Revista colombiana de anestesiología, 40(4), 304-308.

Reference Type BACKGROUND

Mian A, Chaudhry I, Huang R, Rizk E, Tubbs RS, Loukas M. Brachial plexus anesthesia: A review of the relevant anatomy, complications, and anatomical variations. Clin Anat. 2014 Mar;27(2):210-21. doi: 10.1002/ca.22254. Epub 2013 Aug 20.

Reference Type BACKGROUND
PMID: 23959836 (View on PubMed)

Dzul-Martín, C., y Torres-Anaya, C. (2016). Actualidades en el bloqueo de plexo braquial. Revista mexicana de anestesiología, 39(1), 272-275.

Reference Type BACKGROUND

Other Identifiers

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CONBIOETICA-24-C1-20160427

Identifier Type: -

Identifier Source: org_study_id

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