- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06493643
Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block
August 3, 2024 updated by: Ain Shams University
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 .
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
43
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients undergoing elective hand surgeries at El-demerdash Hospital of Surgery during the study period.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 . |
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Perfusion index ( PI ) ratio was recorded at baseline and 10 minutes after local anaesthetic injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 12, 2024
First Submitted That Met QC Criteria
July 7, 2024
First Posted (Actual)
July 10, 2024
Study Record Updates
Last Update Posted (Actual)
August 6, 2024
Last Update Submitted That Met QC Criteria
August 3, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- FMASU MS 726/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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