Clinical trial NCT06915519: Predictive Value Of Muscle Tone And Perfusion Index In Supraclavicular Block Success.
Official title: Predictive Value Of Muscle Tone Loss And Perfusion Index In The Success Of Supraclavicular Brachial Plexus Block: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia Success
Orthopedic Surgery
Keywords: supraclavicular block
regional anesthesia
perfusion index
motor strength
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: measurement of motor strength with the flexometer in the blocked hand at 0, 5, 10, 15 minutes post blockage
timeFrame: Periprocedural
measure: measurement of sympathetic block with perfusion index in the blocked hand
timeFrame: Periprocedural
Secondary outcomes:
measure: success of supraclavicular block
timeFrame: Periprocedural
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital General "Dr. Ignacio Morones Prieto"
state: San Luis
Study officials:
affiliation: anesthesia department
name: Marco A Govea-Hernandez, Anesthesiologist
role: STUDY_DIRECTOR
affiliation: Anesthesiology Departmen
name: Mauricio Guerra-Hernandez, Medical Doctor
role: STUDY_CHAIR
affiliation: Clinical Investigation Department
name: Venance Basil-Kway, Medical Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Dzul-Martín, C., y Torres-Anaya, C. (2016). Actualidades en el bloqueo de plexo braquial. Revista mexicana de anestesiología, 39(1), 272-275.