Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular BlockNCT03880201
Perfusion Index in Detection of Ulnar Nerve Sparing During Supraclavicular Block
An observational study of Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block and Perfusion Index as an Early Predictor of Successful Supraclavicular Block, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block, Perfusion Index as an Early Predictor of Successful Supraclavicular Block
- What is being tested?
- ultrasound guided supraclavicular block and Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2019to 28 Jun 2019
- How long will I take part?
- 1 Day
- 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 18 to 60 years
- All sexes
- Adult
Study population: The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block.
Who may be able to join
- Age between 18 and 60 years and weight 60-90 kg.
- ASA physical status classification I- II
- Patients scheduled for elective upper limb surgery
Who cannot join
- • upper limb ischemia
- Diabetic neuropathy
- Known contraindications to regional anaesthetic techniques as coagulopathy.
- ASA physical status class III-IV.
- Hypovolemic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Ability of Perfusion Index in Detection of Ulnar Nerve Sparing During Ultra Sound Guided Supraclavicular Block
The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block.
Read the detailed description
On arrival to the operating room, patients will be connected to standard continuous monitoring; i.e. 5 lead electrocardiography (ECG), pulse oximetry, and automated non-invasive blood pressure monitoring (NIBP) every 5 minute. Two radical-7 (masimo set) devices will be connected the patient through two probes. The probes will be connected to both index and fifth digit to have a baseline reading before block performance. After block performance, PI will be continuously monitored for 30 minutes.
2-Anesthetic technique
Supraclavicular block:
Equipment and preparation:
- Ultrasound machine with linear transducer (8-14 MHz) (Siemens acusonx300, Korea).
- 5-cm, 22-gauge insulated block needle
- Sterile gloves, sterile sleeve, and gel (Or other coupling medium; e.g. Saline)
- 20 to 25 ml of 0.5% bupivacaine + 2% lidocaine in equal volumes
Patient position:
The block can be performed while the patient is in the supine, semi-sitting, with the Patient's head turned away from the side to be blocked with slight elevation of the head of the bed which is often more comfortable for the Patient and allows for better drainage and less prominence of the neck veins.
Technique:
After sterilization and local anaesthetic infiltration of skin, the linear transducer will be applied firmly above the clavicle in the coronal oblique plane to view the transverse section of the subclavian artery, pleura, first rib and brachial plexus (which is recognized as around or oval compact groups of hypo-echoic nerves, located lateral and superficial to the pulsatile subclavian artery and superior to the first rib). The 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The block needle will be advanced along the long axis of the transducer (from lateral to medial). The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected so as to cause hydro dissection of the planes around the plexus the volume of local Anesthetic used is usually between 20 to 25 ml.
Motor block will be assessed as inability to flex elbow and hand joints against gravity and will be tested for each nerve as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch (15). Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves. This assessment will take place every 5 minutes till 30 minutes and the block will be considered failed if the patient reports pain at the examined dermatomes during assessment time which needs conversion to general anesthesia. If the patient reports no sensation in the whole upper limb apart from the dermatomes supplied by ulnar nerve, which is not relieved after local infiltration of skin by local anesthetic this will be considered ulnar nerve sparing.
The block assessment will be correlated with Masimo pulse oximetry readings during the first 30 minutes of the block.
Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 10 minutes then every 3 minutes for 7 readings.
Monitoring of HR, MAP and pulse oximetry will be recorded before the block and every 5 minutes for 30 minutes after the block, then every 15 minutes till the end of surgery.
- Conditions
- Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block, Perfusion Index as an Early Predictor of Successful Supraclavicular Block
- Being tested
- ultrasound guided supraclavicular block, Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)
- Keywords
- perfusion index.ulnar nerve sparing. supraclavicular blocK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided supraclavicular blockProcedure or surgery
The linear transducer will be applied firmly above the clavicle in the coronal oblique plane the 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected between 20 to 25 ml.
Motor block will be assessed as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch.
Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves.
Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)Device
Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 20 minutes then every 3 minutes for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| patient undergoing upper limb orthopaedic surgery | The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block. Receives: Procedure: ultrasound guided supraclavicular block; Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PI ratio in the little digit
PI ratio is defined as PI at 10 minutes / PI at the baseline
Measured: 10 minutes after block
Secondary outcomes (6)
PI ratio in the index digit
PI ratio is defined as PI at 10 minutes / PI at the baseline
Measured: 10 minutes after block
PI values in the index digit
PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.
Measured: every minute for 20 minutes then every 3 minutes for 30 minutes
PI values in the little digit
PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.
Measured: every minute for 20 minutes then every 3 minutes for 30 minutes
Time needed to reach the maximum PI
PI values is recorded every minute for 20 minutes then every 3 minutes for 30 minutes.
Measured: every minute for 20 minutes then every 3 minutes for 30 minutes.
Time needed to reach the maximum PI ratio
PI ratio is calculated as PI at each minute after block / PI at the baseline
Measured: every minute for 20 minutes then every 3 minutes for 30 minutes.
Incidence of ulnar nerve sparing
Measured: for 30 minutes after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start20 Mar 2019
- Primary completion20 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Ahmed Hasanin, MD, Principal investigator, Cairo UniversityBassant abdelhamid, MD, Principal investigator, Cairo UniversityMohamed Emam, Master, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880201
- Sponsor's protocol ID
- N-30-2018
- Status last verified
- Jul 2019
- First submitted
- 15 Mar 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith GB, Wilson GR, Curry CH, May SN, Arthurson GM, Robinson DA, Cross GD. Predicting successful brachial plexus block using changes in skin electrical resistance. Br J Anaesth. 1988 May;60(6):703-8. doi: 10.1093/bja/60.6.703.
PubMed 3377954Sorensen J, Bengtsson M, Malmqvist EL, Nilsson G, Sjoberg F. Laser Doppler perfusion imager (LDPI)--for the assessment of skin blood flow changes following sympathetic blocks. Acta Anaesthesiol Scand. 1996 Oct;40(9):1145-8. doi: 10.1111/j.1399-6576.1996.tb05578.x.
PubMed 8933857Galvin EM, Niehof S, Medina HJ, Zijlstra FJ, van Bommel J, Klein J, Verbrugge SJ. Thermographic temperature measurement compared with pinprick and cold sensation in predicting the effectiveness of regional blocks. Anesth Analg. 2006 Feb;102(2):598-604. doi: 10.1213/01.ane.0000189556.49429.16.
PubMed 16428569Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
PubMed 12580205Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.
PubMed 23397432Abdelnasser 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 28854539Abdelhamid B, Emam M, Mostafa M, Hasanin A, Awada W, Rady A, Omar H. The ability of perfusion index to detect segmental ulnar nerve sparing after supraclavicular nerve block. J Clin Monit Comput. 2020 Dec;34(6):1185-1191. doi: 10.1007/s10877-019-00443-4. Epub 2019 Dec 9.
PubMed 31820214
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of Perfusion Index in Detection of Ulnar Nerve Sparing During Ultra Sound Guided Supraclavicular Block
- ClinicalTrials.gov ID
- NCT03880201
- Acronym / sponsor ID
- N-30-2018
- Conditions
- Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block, Perfusion Index as an Early Predictor of Successful Supraclavicular Block
- Keywords
- perfusion index.ulnar nerve sparing. supraclavicular blocK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 19 Mar 2019 (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.
The aim of this study to evaluate the ability of perfusion index to detect ulnar sparing and to estimate the proper time for the perfusion index ratio to determine successful block.
Detailed description
On arrival to the operating room, patients will be connected to standard continuous monitoring; i.e. 5 lead electrocardiography (ECG), pulse oximetry, and automated non-invasive blood pressure monitoring (NIBP) every 5 minute. Two radical-7 (masimo set) devices will be connected the patient through two probes. The probes will be connected to both index and fifth digit to have a baseline reading before block performance. After block performance, PI will be continuously monitored for 30 minutes.
2-Anesthetic technique
Supraclavicular block:
Equipment and preparation:
- Ultrasound machine with linear transducer (8-14 MHz) (Siemens acusonx300, Korea).
- 5-cm, 22-gauge insulated block needle
- Sterile gloves, sterile sleeve, and gel (Or other coupling medium; e.g. Saline)
- 20 to 25 ml of 0.5% bupivacaine + 2% lidocaine in equal volumes
Patient position:
The block can be performed while the patient is in the supine, semi-sitting, with the Patient's head turned away from the side to be blocked with slight elevation of the head of the bed which is often more comfortable for the Patient and allows for better drainage and less prominence of the neck veins.
Technique:
After sterilization and local anaesthetic infiltration of skin, the linear transducer will be applied firmly above the clavicle in the coronal oblique plane to view the transverse section of the subclavian artery, pleura, first rib and brachial plexus (which is recognized as around or oval compact groups of hypo-echoic nerves, located lateral and superficial to the pulsatile subclavian artery and superior to the first rib). The 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The block needle will be advanced along the long axis of the transducer (from lateral to medial). The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected so as to cause hydro dissection of the planes around the plexus the volume of local Anesthetic used is usually between 20 to 25 ml.
Motor block will be assessed as inability to flex elbow and hand joints against gravity and will be tested for each nerve as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch (15). Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves. This assessment will take place every 5 minutes till 30 minutes and the block will be considered failed if the patient reports pain at the examined dermatomes during assessment time which needs conversion to general anesthesia. If the patient reports no sensation in the whole upper limb apart from the dermatomes supplied by ulnar nerve, which is not relieved after local infiltration of skin by local anesthetic this will be considered ulnar nerve sparing.
The block assessment will be correlated with Masimo pulse oximetry readings during the first 30 minutes of the block.
Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 10 minutes then every 3 minutes for 7 readings.
Monitoring of HR, MAP and pulse oximetry will be recorded before the block and every 5 minutes for 30 minutes after the block, then every 15 minutes till the end of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient undergoing upper limb orthopaedic surgery | – | Procedure: ultrasound guided supraclavicular block, Device: Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study will be performed on patient undergoing upper limb orthopaedic surgery which will be performed under ultrasound guided supraclavicular block.
Key inclusion criteria (3 listed)
- Age between 18 and 60 years and weight 60-90 kg.
- ASA physical status classification I- II
- Patients scheduled for elective upper limb surgery
Key exclusion criteria (5 listed)
- • upper limb ischemia
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 |
|---|---|---|
| ultrasound guided supraclavicular blockThe linear transducer will be applied firmly above the clavicle in the coronal oblique plane the 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected between 20 to 25 ml. Motor block will be assessed as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch. Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves. | Procedure or surgery | patient undergoing upper limb orthopaedic surgery |
| Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 20 minutes then every 3 minutes for 30 minutes. | Device | patient undergoing upper limb orthopaedic surgery |
Primary outcome
PI ratio in the little digit
Time frame: 10 minutes after block
PI ratio is defined as PI at 10 minutes / PI at the baseline
6 secondary outcomes
PI ratio in the index digit
Time frame: 10 minutes after block
PI values in the index digit
Time frame: every minute for 20 minutes then every 3 minutes for 30 minutes
PI values in the little digit
Time frame: every minute for 20 minutes then every 3 minutes for 30 minutes
Time needed to reach the maximum PI
Time frame: every minute for 20 minutes then every 3 minutes for 30 minutes.
Time needed to reach the maximum PI ratio
Time frame: every minute for 20 minutes then every 3 minutes for 30 minutes.
Incidence of ulnar nerve sparing
Time frame: for 30 minutes after block
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 9 Jul 2019.
- Background: PubMed 3377954Smith GB, Wilson GR, Curry CH, May SN, Arthurson GM, Robinson DA, Cross GD. Predicting successful brachial plexus block using changes in skin electrical resistance. Br J Anaesth. 1988 May;60(6):703-8. doi: 10.1093/bja/60.6.703.
- Background: PubMed 8933857Sorensen J, Bengtsson M, Malmqvist EL, Nilsson G, Sjoberg F. Laser Doppler perfusion imager (LDPI)--for the assessment of skin blood flow changes following sympathetic blocks. Acta Anaesthesiol Scand. 1996 Oct;40(9):1145-8. doi: 10.1111/j.1399-6576.1996.tb05578.x.
- Background: PubMed 16428569Galvin EM, Niehof S, Medina HJ, Zijlstra FJ, van Bommel J, Klein J, Verbrugge SJ. Thermographic temperature measurement compared with pinprick and cold sensation in predicting the effectiveness of regional blocks. Anesth Analg. 2006 Feb;102(2):598-604. doi: 10.1213/01.ane.0000189556.49429.16.
- Background: PubMed 12580205Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
- Background: PubMed 23397432Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.
- 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.
- Derived from this study: PubMed 31820214Abdelhamid B, Emam M, Mostafa M, Hasanin A, Awada W, Rady A, Omar H. The ability of perfusion index to detect segmental ulnar nerve sparing after supraclavicular nerve block. J Clin Monit Comput. 2020 Dec;34(6):1185-1191. doi: 10.1007/s10877-019-00443-4. Epub 2019 Dec 9.
- Individual participant dataSharing planned: No
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.
Ahmed Hasanin, MD principal investigator
Cairo University
Bassant abdelhamid, MD principal investigator
Cairo University
Mohamed Emam, Master study director
Cairo University
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 Perfusion Index as an Early Predictor of Ulnar Nerve Sparing in Supraclavicular Block and Perfusion Index as an Early Predictor of Successful Supraclavicular Block, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 9 Jul 2019. 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 Egypt. 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?
PI ratio in the little digit (time frame: 10 minutes after 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 NCT03880201, which also lists 7 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 9 Jul 2019.