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Regional Anesthesia SuccessPREVAMNCT06915519

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

An observational study of Regional Anesthesia Success and Orthopedic Surgery, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
measure motor strength and perfusion index
How many people
33 participants
Where
1 siteMexico
Study dates
1 Mar 2023to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, San Luis Potosí, 78250

Other trials in Mexico

About this study

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

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.

Being tested
measure motor strength and perfusion index
Keywords
supraclavicular block, regional anesthesia, perfusion index, motor strength

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measure motor strength and perfusion indexDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: Periprocedural

Secondary outcomes (1)

  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.

    Measured: Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start1 Mar 2023
  3. Primary completion1 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06915519
Sponsor's protocol ID
CONBIOETICA-24-C1-20160427
Acronym
PREVAM
Status last verified
Apr 2025
First submitted
18 Mar 2025
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Regional Anesthesia Success and Orthopedic Surgery, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurement of motor strength with the flexometer in the blocked hand at 0, 5, 10, 15 minutes post blockage (time frame: Periprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06915519, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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