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Not yet recruitingNCT06493643Updated Aug 6, 2024

Peripheral Perfusion Index as a Predictor of Successful Supraclavicular Brachial Plexus Block

An observational study in Perfusion Index, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Ain Shams University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
15 Years to 60 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Perfusion Index

Keywords

  • Supraclavicular block
  • Brachial plexus block
  • Perfusion index ( PI )
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 .

    Other: Measurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb

Interventions

  • OtherMeasurement of perfusion index after supraclavicular brachial plexus block at blocked & unblocked limb

    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 .

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    Time frame: Perfusion index ( PI ) ratio was recorded at baseline and 10 minutes after local anaesthetic injection

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06493643
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Jul 10, 2024
Start date
Aug 2024 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Aug 6, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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