Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

NCT ID: NCT04925505

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2024-07-05

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.

Conditions

Disorder of Shoulder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

BPB success

The study included patients aged between 20 and 70 yr who are to undergo elective shoulder surgery under general anesthesia. Patients undergo general anesthesia induction before the interscalene block is performed. Ultrasound-guided interscalene brachial plexus block will be performed in anesthetized patients before surgery. PI monitor will be applied to both blocked and non-blocked limbs using two separate oximeters. And the SUCCESS (or failure) of the block will be confirmed by (1) 30% change of heart rate and blood pressure after incision during operation, and (2) pain score, motor and sensory function test after surgery in the post-anesthesia recovery unit.

Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

Intervention Type: PROCEDURE

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

BPB failure

The study included patients aged between 20 and 70 yr who are to undergo elective shoulder surgery under general anesthesia. Patients undergo general anesthesia induction before the interscalene block is performed. Ultrasound-guided interscalene brachial plexus block will be performed in anesthetized patients before surgery. PI monitor will be applied to both blocked and non-blocked limbs using two separate oximeters. And the (success or) FAILURE of the block will be confirmed by (1) 30% change of heart rate and blood pressure after incision during operation, and (2) pain score, motor and sensory function test after surgery in the post-anesthesia recovery unit.

Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seok Kyeong Oh

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 28854539 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20708419 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28696947 (View on PubMed)

Other Identifiers

2021GR0104

Identifier Type: -

Identifier Source: org_study_id