Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

NCT04925505 | Completed

• 1 other identifier: 2021GR0104
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Disorder of Shoulder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Heart rate

  change between before and 5 minutes after incision of surgical procedure

• Blood pressure

  change between before and 5 minutes after incision of surgical procedure

• Pain score

  1 hour after surgery

• Sensory function test on supraclavicular nerve and axillary nerve

  1 hour after surgery

• Motor function test on supraclavicular nerve and axillary nerve and

  1 hour after surgery

Study Arms (2)

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.

Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

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.

Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

Interventions

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

BPB failure; BPB success

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related 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.

  PMID: 28854539 BACKGROUND

• 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.

  PMID: 20708419 BACKGROUND

• 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.

  PMID: 28696947 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 14, 2021
• Study Start: June 3, 2021
• Primary Completion: May 27, 2024
• Study Completion: July 5, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Locations

KR (1)