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

Completed

• Conditions: Regional Anesthesia Success; Orthopedic Surgery

• Registration Number: NCT06915519
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

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.

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-31
• Study First Submitted: 2025-03-18
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measurement of motor strength with the flexometer in the blocked hand at 0, 5, 10, 15 minutes post blockage	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.
measurement of sympathetic block with perfusion index in the blocked hand	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 Outcome Measures

Name	Time	Method
success of supraclavicular block	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.

Trial Locations

Locations (1)

Hospital General "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosi, San Luis, Mexico