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NCT Number: NCT04921891

Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block

The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Perfusion Index Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

About this study

Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages of 18-75
  • Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
  • ASA I-II-III patients

Exclusion criteria

  • Patients who will refuse this method
  • Neurological deficits,
  • Diabetes mellitus,
  • Local anesthetic allergy,
  • Morbidly obese,
  • Peripheral vascular disease, coronary artery disease, or coagulopathy

Treatment and study plan

Infraclavicular nerve block

Procedure

The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.

Without nerve block

Procedure

The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

Primary outcomes

  1. Evaluation of whether perfusion index is a reliable and objective method to indicate block success

    Time frame: 6 hours postprocedurly

    Perfusion index was measured up to 6 hours after the procedure.

Secondary outcomes

  1. Determining of a cut-off value for PI and PI ratio for a successful block.

    Time frame: Up to 6 hours after the procedure

    There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

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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