Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04925505
Collaborator
(none)
70
1
32.9
2.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia
Actual Study Start Date :
Jun 3, 2021
Anticipated Primary Completion Date :
Jun 6, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. Perfusion Index [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 Outcome Measures

  1. Heart rate [change between before and 5 minutes after incision of surgical procedure]

    heart rate in bpm during operation

  2. Blood pressure [change between before and 5 minutes after incision of surgical procedure]

    blood pressure in mmHg during operation

  3. Pain score [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 [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 [1 hour after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital Seoul Korea, Republic of 08308

Sponsors and Collaborators

  • Korea University Guro Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Seok Kyeong Oh, Assistant professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT04925505
Other Study ID Numbers:
  • 2021GR0104
First Posted:
Jun 14, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022