Disorder of ShoulderNCT04925505
Perfusion Index for Predicting Brachial Plexus Block Success Under General Anesthesia
An observational study of Disorder of Shoulder, run by Korea University Guro Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Disorder of Shoulder
- What is being tested?
- Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2021to 5 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients aged 20-70 who are scheduled for shoulder surgery under general anesthesia, with ASA physical status I-III
Who may be able to join
- 20-70 years old,
- BMI 20-35 kg.m-2,
- elective shoulder surgery,
- ASA physical status I-III
Who cannot join
- refusal of the patient,
- comorbid with serious vascular disease,
- diabetes,
- allergy to local anesthetics,
- patients on regular opioids,
- peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anaesthesiology and Pain Medicine, Korea University Guro Hospital
Seoul, 08308
About this study
Official title: Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia
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).
Read the 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
- Being tested
- Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blocks with ultrasound guidance under general anesthesiaProcedure or surgery
Ultrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion Index
perfusion index measured applied to both blocked and non-blocked limbs using two separate oximeters
Measured: change between before and 15 minutes after brachial plexus block
Secondary outcomes (5)
Heart rate
heart rate in bpm during operation
Measured: change between before and 5 minutes after incision of surgical procedure
Blood pressure
blood pressure in mmHg during operation
Measured: change between before and 5 minutes after incision of surgical procedure
Pain score
Numeric rating scale for pain on a 0-10 scale where 0=no pain and 10=unbearable pain
Measured: 1 hour after surgery
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)
Measured: 1 hour after surgery
Motor function test on supraclavicular nerve and axillary nerve and
0-2 scale where 0 = no block; 1 = paresis; 2 = paralysis
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start3 Jun 2021
- Primary completion27 May 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorder of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Kyeong Oh, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925505
- Sponsor's protocol ID
- 2021GR0104
- Status last verified
- Jan 2025
- First submitted
- 2 Jun 2021
- Last updated
- 3 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28854539Misamore 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.
PubMed 20708419Marhofer 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.
PubMed 28696947
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Pulse Oximeter Perfusion Index for Predicting the Success of Interscalene Brachial Plexus Blockade Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04925505
- Acronym / sponsor ID
- 2021GR0104
- Conditions
- Disorder of Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPB success | – | Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesiaThe 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. |
| BPB failure | – | Procedure: Interscalene brachial plexus blocks with ultrasound guidance under general anesthesiaThe 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients aged 20-70 who are scheduled for shoulder surgery under general anesthesia, with ASA physical status I-III
Key inclusion criteria (4 listed)
- 20-70 years old,
- BMI 20-35 kg.m-2,
- elective shoulder surgery,
- ASA physical status I-III
Key exclusion criteria (6 listed)
- refusal of the patient,
- comorbid with serious vascular disease,
- diabetes,
- allergy to local anesthetics,
- patients on regular opioids,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blocks with ultrasound guidance under general anesthesiaUltrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml | Procedure or surgery | BPB failure, BPB success |
Primary outcome
Perfusion Index
Time frame: 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
5 secondary outcomes
Heart rate
Time frame: change between before and 5 minutes after incision of surgical procedure
Blood pressure
Time frame: change between before and 5 minutes after incision of surgical procedure
Pain score
Time frame: 1 hour after surgery
Sensory function test on supraclavicular nerve and axillary nerve
Time frame: 1 hour after surgery
Motor function test on supraclavicular nerve and axillary nerve and
Time frame: 1 hour after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 28854539Abdelnasser 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.
- Background: PubMed 20708419Misamore 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.
- Background: PubMed 28696947Marhofer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Shoulder, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion Index (time frame: change between before and 15 minutes after brachial plexus block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925505, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.