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NCT Number: NCT04925505

Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

This study was designed to determine whether the success or failure of interscalene brachial plexus block under general anesthesia can be predicted using perfusion index (PI).

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Key information

Conditions

Disorder of Shoulder

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Seoul, 08308, South Korea

About this study

The success of peripheral nerve blocks is usually evaluated by assessment of sensory and motor function; however, this method cannot be applied in the patient who has uncheckable mental status, e.g. general anesthesia, or who is uncommunicable, e.g. different language user.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter, and PI had been proved as a useful tool for evaluation of successful supraclavicular nerve block in awake patients as an objective method.

With the use of ultrasound guidance in skilled hands, it is a reasonable option to perform neuraxial and peripheral regional blocks in sedated or anesthetized patients. However, there has been no evidence of applying PI for predicting the success of nerve block in general anesthetized patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20-70 years old,
  • BMI 20-35 kg.m-2,
  • elective shoulder surgery,
  • ASA physical status I-III

Exclusion criteria

  • refusal of the patient,
  • comorbid with serious vascular disease,
  • diabetes,
  • allergy to local anesthetics,
  • patients on regular opioids,
  • peripheral neuropathy.

Treatment and study plan

Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

Procedure

Ultrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml

Primary outcomes

  1. Perfusion Index

    Time frame: change between before and 15 minutes after brachial plexus block

    perfusion index measured applied to both blocked and non-blocked limbs using two separate oximeters

Secondary outcomes

  1. Heart rate

    Time frame: change between before and 5 minutes after incision of surgical procedure

    heart rate in bpm during operation

  2. Blood pressure

    Time frame: change between before and 5 minutes after incision of surgical procedure

    blood pressure in mmHg during operation

  3. Pain score

    Time frame: 1 hour after surgery

    Numeric rating scale for pain on a 0-10 scale where 0=no pain and 10=unbearable pain

  4. Sensory function test on supraclavicular nerve and axillary nerve

    Time frame: 1 hour after surgery

    0-2 scale where 0=no block; 1=analgesia (patient can feel touch, not cold); 2=anesthesia (patient cannot feel touch)

  5. Motor function test on supraclavicular nerve and axillary nerve and

    Time frame: 1 hour after surgery

    0-2 scale where 0 = no block; 1 = paresis; 2 = paralysis

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2021
Registry last updated
Jan 3, 2025

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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