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Completed

NCT Number: NCT06915519

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

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 .

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Key information

Conditions

Regional Anesthesia Success Orthopedic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General "Dr. Ignacio Morones Prieto"

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Periprocedural

    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.

  2. measurement of sympathetic block with perfusion index in the blocked hand

    Time frame: Periprocedural

    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.

Secondary outcomes

  1. success of supraclavicular block

    Time frame: Periprocedural

    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.

Sponsors and collaborators

Lead sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Other

Registry information

Official study title

Predictive Value Of Muscle Tone Loss And Perfusion Index In The Success Of Supraclavicular Brachial Plexus Block: A Pilot Study

Acronym: PREVAM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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