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

NCT06915519 | Completed DMC

• 1 other identifier: CONBIOETICA-24-C1-20160427
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Regional Anesthesia Success; Orthopedic Surgery

Keywords

supraclavicular block; regional anesthesia; perfusion index; motor strength

Outcome Measures

Primary Outcomes (2)

• measurement of motor strength with the flexometer in the blocked hand at 0, 5, 10, 15 minutes post blockage

  the patient will be asked to move the third finger of the blocked hand which will be connected to the flexometer to measure the motor strength at 0, 5, 10 and 15 minutes and correlate with the successfulness of the block.

  Periprocedural

• measurement of sympathetic block with perfusion index in the blocked hand

  measurement of the perfusion index in the blocked hand at 0, 5, 10 and 15 minutes post blockage and correlate with the sympathetic block and successfulness of the supraclavicular block.

  Periprocedural

Secondary Outcomes (1)

• success of supraclavicular block

  Periprocedural

Interventions

measure motor strength and perfusion index DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled to orthopedic surgery of the upper limb in the Hospital General "Dr. Ignacio Morones Prieto" in San Luis Potosi, Mexico.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital General "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

Related Publications (5)

• 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.

  PMID: 22030724 BACKGROUND

• 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.

  PMID: 19282715 BACKGROUND

• 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.

  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.

  PMID: 23959836 BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marco A Govea-Hernandez, Anesthesiologist

  anesthesia department

  STUDY DIRECTOR

• Mauricio Guerra-Hernandez, Medical Doctor

  Anesthesiology Departmen

  STUDY CHAIR

• Venance Basil-Kway, Medical Doctor

  Clinical Investigation Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 8, 2025
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

ME (1)