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CompletedNCT06915519PREVAMUpdated Apr 8, 2025

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

An observational study in Regional Anesthesia Success and Orthopedic Surgery, sponsored by Hospital Central "Dr. Ignacio Morones Prieto". Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Hospital Central "Dr. Ignacio Morones Prieto" · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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 .

Read the detailed description

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.

02

Conditions studied

  • Regional Anesthesia Success
  • Orthopedic Surgery

Keywords

  • supraclavicular block
  • regional anesthesia
  • perfusion index
  • motor strength
03

In context

Lead sponsor

Hospital Central "Dr. Ignacio Morones Prieto" is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testmeasure 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Periprocedural

  2. 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.

    Time frame: Periprocedural

Secondary outcomes

  1. success of supraclavicular block

    measure the success of the block defined as Numeric Scale Rate (NRS from 0 to 10) less 2 and absence to change the anesthetic technique during the surgery. Less NRS is correlated with successfulness of the blockage.

    Time frame: Periprocedural

07

Study locations

1 site
  • Hospital General "Dr. Ignacio Morones Prieto"
    San Luis Potosi, San Luis 78250, Mexico
08

References and documents

Publications

  • 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. PubMed 22030724 ↗
  • 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. PubMed 19282715 ↗
  • 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.
  • 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. PubMed 23959836 ↗
  • Dzul-Martín, C., y Torres-Anaya, C. (2016). Actualidades en el bloqueo de plexo braquial. Revista mexicana de anestesiología, 39(1), 272-275.

Individual participant data

Plan to share: Undecided — at the moment, the patients data are confidential, so, we haven't decide to share with other investigators. only data used in the results will be available.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06915519
Lead sponsor
Hospital Central "Dr. Ignacio Morones Prieto"
Responsible party
Gloria Fabiola Alvarez-Orenday (Anesthesiologist, Hospital Central "Dr. Ignacio Morones Prieto") — Principal investigator
First posted
Apr 8, 2025
Start date
Mar 1, 2023
Primary completion
Mar 1, 2024
Completion
Mar 31, 2024
Last update
Apr 8, 2025

Study contacts

Marco A Govea-Hernandez, Anesthesiologist
study director · anesthesia department
Mauricio Guerra-Hernandez, Medical Doctor
study chair · Anesthesiology Departmen
Venance Basil-Kway, Medical Doctor
study director · Clinical Investigation Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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