Perfusion IndexNCT06493643
Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block
An observational study of Perfusion Index, run by Ain Shams University.
Trial summary
Aim of the study is to determine the best cut off value for the PI and PI ratio for predication of successful supraclavicular brachial plexus block in young and middle age patients undergoing hand surgeries . Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Perfusion Index
- What is being tested?
- Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb
- Type of treatment
- Injection or infusion
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Dec 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients undergoing elective hand surgeries at El-demerdash Hospital of Surgery during the study period.
Who may be able to join
- Adult patients aging between 15_ 60 years of both sexes.
- Patients undergoing Elective hand Surgeries under successful supraclavicular brachial plexus block anesthesia.
- American Society of Anesthesiologists (ASA) physical status classes I - II.
Who cannot join
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Contraindications to supraclavicular brachial plexus block anesthesia such as local infection.
- Hypersensitivity to the study medications.
- Diabetes mellitus.
- Peripheral vascular disease.
- Emergency surgeries.
About this study
Official title: Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block in Patients Undergoing Hand Surgeries
Aim of the study is to determine the best cut off value for the PI and PI ratio for predication of successful supraclavicular brachial plexus block in young and middle age patients undergoing hand surgeries .
Read the detailed description
- The supraclavicular nerve block was performed under guidance of a linear transducer (8-14 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea) over the supraclavicular fossa in the coronal oblique plane immediately superior to the midclavicular point. The block was induced in the semi-sitting position, with the head of the patient turned away from the side to be blocked.
- The PI was measured using Masimo SET pulse oximeter, applied on the index finger. The PI was recorded at baseline and at 10, 20, and 30min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters.
- The PI ratio was calculated as the ratio between the PI at 10min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb was performed.
- PI was recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
- PI ratio was calculated as the ratio between the PI at 10 min after injection and the baseline PI.
- Vital data (Blood pressure, Heart rate, SPO2) was recorded before giving the block and at 10, 20, and 30 min after local anaesthetic injection and at the end of the operation.
- Conditions
- Perfusion Index
- Being tested
- Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb
- Keywords
- Supraclavicular block, Brachial plexus block, Perfusion index ( PI )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limbOther
The PI (Perfusion Index) was measured using Masimo SET pulse oximetry applied on the index finger. The PI was recorded at baseline and at 10 , 20 , and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters. The PI ratio was calculated as the ratio between the PI at 10min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb was performed .
| Study group | Role | What they receive |
|---|---|---|
| Perfusion index at the blocked & unblocked limb | The Perfusion Index was recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters.
In every patient , a comparison between the blocked and unblocked limb was performed . Receives: Other: Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut off value for perfusion index ( PI ) for predication of successful supraclavicular brachial plexus block.
Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
Measured: Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
Cut off value for perfusion index (PI) ratio for predication of successful supraclavicular brachial plexus block.
Perfusion index (PI) ratio was calculated as the ratio between the PI at 10 minutes after injection and the baseline PI.
Measured: Perfusion index ( PI ) ratio was recorded at baseline and 10 minutes after local anaesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion IndexStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493643
- Sponsor's protocol ID
- FMASU MS 726/2023
- Status last verified
- Dec 2023
- First submitted
- 12 May 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block in Patients Undergoing Hand Surgeries
- ClinicalTrials.gov ID
- NCT06493643
- Acronym / sponsor ID
- FMASU MS 726/2023
- Conditions
- Perfusion Index
- Keywords
- Supraclavicular block, Brachial plexus block, Perfusion index ( PI )
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jul 2024 (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.
Aim of the study is to determine the best cut off value for the PI and PI ratio for predication of successful supraclavicular brachial plexus block in young and middle age patients undergoing hand surgeries .
Detailed description
- The supraclavicular nerve block was performed under guidance of a linear transducer (8-14 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea) over the supraclavicular fossa in the coronal oblique plane immediately superior to the midclavicular point. The block was induced in the semi-sitting position, with the head of the patient turned away from the side to be blocked.
- The PI was measured using Masimo SET pulse oximeter, applied on the index finger. The PI was recorded at baseline and at 10, 20, and 30min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters.
- The PI ratio was calculated as the ratio between the PI at 10min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb was performed.
- PI was recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
- PI ratio was calculated as the ratio between the PI at 10 min after injection and the baseline PI.
- Vital data (Blood pressure, Heart rate, SPO2) was recorded before giving the block and at 10, 20, and 30 min after local anaesthetic injection and at the end of the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perfusion index at the blocked & unblocked limb | – | Other: Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limbThe Perfusion Index was recorded at baseline and at 10, 20, and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters. In every patient , a comparison between the blocked and unblocked limb was performed . |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients undergoing elective hand surgeries at El-demerdash Hospital of Surgery during the study period.
Key inclusion criteria (3 listed)
- Adult patients aging between 15_ 60 years of both sexes.
- Patients undergoing Elective hand Surgeries under successful supraclavicular brachial plexus block anesthesia.
- American Society of Anesthesiologists (ASA) physical status classes I - II.
Key exclusion criteria (8 listed)
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Contraindications to supraclavicular brachial plexus block anesthesia such as local infection.
- Hypersensitivity to the study medications.
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 |
|---|---|---|
| Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limbThe PI (Perfusion Index) was measured using Masimo SET pulse oximetry applied on the index finger. The PI was recorded at baseline and at 10 , 20 , and 30 min after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb using two separate oximeters. The PI ratio was calculated as the ratio between the PI at 10min after injection and the baseline PI. In every patient, a comparison between the blocked and unblocked limb was performed . | Other | Perfusion index at the blocked & unblocked limb |
Primary outcome
Cut off value for perfusion index ( PI ) for predication of successful supraclavicular brachial plexus block.
Time frame: Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.
Cut off value for perfusion index (PI) ratio for predication of successful supraclavicular brachial plexus block.
Time frame: Perfusion index ( PI ) ratio was recorded at baseline and 10 minutes after local anaesthetic injection
Perfusion index (PI) ratio was calculated as the ratio between the PI at 10 minutes after injection and the baseline PI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perfusion Index, run by Ain Shams University.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Cut off value for perfusion index ( PI ) for predication of successful supraclavicular brachial plexus block. (time frame: Perfusion index (PI) was recorded at baseline and at 10, 20, and 30 minutes after local anaesthetic injection in both the blocked limb and the contralateral unblocked limb.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.