NCT06475638

Brief Summary

Investigators aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

July 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

June 21, 2024

Last Update Submit

January 12, 2025

Conditions

Keywords

pulsatility indexsuccessful blockresistive index

Outcome Measures

Primary Outcomes (1)

  • the change in pulsatility index as a predictor to successful supraclavicular block

    the difference between the index before and after the block divided by the index value before the block

    baseline and at 5 minutes interval after block for 30 minutes

Secondary Outcomes (2)

  • change in resistive index as a predictor for successful block

    baseline then at 5 minutes interval for 30 minutes

  • change in waveform morphology as a predictor to successful block

    baseline and within 10 minutes of block

Interventions

brachial artery doppler evaluation before and after supraclavicular block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patient, ASA 1 and will receive supraclavicular brachial plexus block for forearm or hand surgery

You may qualify if:

  • \- ASA 1 undergoing forearm or hand surgery

You may not qualify if:

  • patient refusal allergy to local anesthetics fracture humerus Diabetes Melitus peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (6)

  • Gamo K, Kuriyama K, Higuchi H, Uesugi A, Nakase T, Hamada M, Kawai H. Ultrasound-guided supraclavicular brachial plexus block in upper limb surgery: outcomes and patient satisfaction. Bone Joint J. 2014 Jun;96-B(6):795-9. doi: 10.1302/0301-620X.96B6.31893.

    PMID: 24891581BACKGROUND
  • Abdelnasser 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.

    PMID: 28854539BACKGROUND
  • Hollenbeck M, Hilbert N, Meusel F, Grabensee B. Increasing sensitivity and specificity of Doppler sonographic detection of renal transplant rejection with serial investigation technique. Clin Investig. 1994 Aug;72(8):609-15. doi: 10.1007/BF00227454.

    PMID: 7819718BACKGROUND
  • Uysal AI, Altiparmak B, Korkmaz Toker M, Dinc Elibol F, Karalezli MN, Demirbilek S. Early and late blood flow changes in the brachial artery following brachial plexus block. Minerva Anestesiol. 2020 Sep;86(9):948-956. doi: 10.23736/S0375-9393.20.14309-8. Epub 2020 Jul 1.

    PMID: 32613812BACKGROUND
  • Li J, Karmakar MK, Li X, Kwok WH, Ngan Kee WD. Regional hemodynamic changes after an axillary brachial plexus block: a pulsed-wave Doppler ultrasound study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):111-8. doi: 10.1097/AAP.0b013e318234007e.

    PMID: 22030722BACKGROUND
  • Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.

    PMID: 2970215BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 26, 2024

Study Start

July 20, 2024

Primary Completion

January 11, 2025

Study Completion

January 11, 2025

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations