NCT06493643

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

May 12, 2024

Last Update Submit

August 3, 2024

Conditions

Keywords

Supraclavicular blockBrachial plexus blockPerfusion index ( PI )

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Study Arms (1)

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

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 .

Perfusion index at the blocked & unblocked limb

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All patients undergoing elective hand surgeries at El-demerdash Hospital of Surgery during the study period.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2024

First Posted

July 10, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

August 6, 2024

Record last verified: 2023-12