Clinical trial NCT04925505: Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia
Official title: Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Shoulder
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 20-70 who are scheduled for shoulder surgery under general anesthesia, with ASA physical status I-III

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perfusion Index
timeFrame: change between before and 15 minutes after brachial plexus block
Secondary outcomes:
measure: Heart rate
timeFrame: change between before and 5 minutes after incision of surgical procedure
measure: Blood pressure
timeFrame: change between before and 5 minutes after incision of surgical procedure
measure: Pain score
timeFrame: 1 hour after surgery
measure: Sensory function test on supraclavicular nerve and axillary nerve
timeFrame: 1 hour after surgery
measure: Motor function test on supraclavicular nerve and axillary nerve and
timeFrame: 1 hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital
Study officials:
References:
citation: Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
citation: Misamore G, Webb B, McMurray S, Sallay P. A prospective analysis of interscalene brachial plexus blocks performed under general anesthesia. J Shoulder Elbow Surg. 2011 Mar;20(2):308-14. doi: 10.1016/j.jse.2010.04.043. Epub 2010 Aug 13.
citation: Marhofer P. Regional blocks carried out during general anesthesia or deep sedation: myths and facts. Curr Opin Anaesthesiol. 2017 Oct;30(5):621-626. doi: 10.1097/ACO.0000000000000504.