Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

Disorder of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04925505
• Other study ID #: 2021GR0104
• Status: Enrolling by invitation
• Start date: June 3, 2021
• Est. completion date: December 28, 2024

Study information

• Verified date: October 2023
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 28, 2024
• Est. primary completion date: June 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disorder of Shoulder

Intervention

Procedure:
• Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia
Ultrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion Index	perfusion index measured applied to both blocked and non-blocked limbs using two separate oximeters	change between before and 15 minutes after brachial plexus block
Secondary	Heart rate	heart rate in bpm during operation	change between before and 5 minutes after incision of surgical procedure
Secondary	Blood pressure	blood pressure in mmHg during operation	change between before and 5 minutes after incision of surgical procedure
Secondary	Pain score	Numeric rating scale for pain on a 0-10 scale where 0=no pain and 10=unbearable pain	1 hour after surgery
Secondary	Sensory function test on supraclavicular nerve and axillary nerve	0-2 scale where 0=no block; 1=analgesia (patient can feel touch, not cold); 2=anesthesia (patient cannot feel touch)	1 hour after surgery
Secondary	Motor function test on supraclavicular nerve and axillary nerve and	0-2 scale where 0 = no block; 1 = paresis; 2 = paralysis	1 hour after surgery