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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06915519
Acronym
PREVAM
Enrollment
33
Registered
2025-04-08
Start date
2023-03-01
Completion date
2024-03-31
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Surgery, Regional Anesthesia Success

Keywords

supraclavicular block, regional anesthesia, perfusion index, motor strength

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 .

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.

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.

Sponsors

Hospital Central Dr. Ignacio Morones Prieto
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measurement of motor strength with the flexometer in the blocked hand at 0, 5, 10, 15 minutes post blockagePeriproceduralthe 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.
measurement of sympathetic block with perfusion index in the blocked handPeriproceduralmeasurement 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

MeasureTime frameDescription
success of supraclavicular blockPeriproceduralmeasure 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026