NCT02989896

Brief Summary

After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 4, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

Perfusion indexPeripheral nerve block successolder age

Outcome Measures

Primary Outcomes (1)

  • patient's perfusion index

    nine month

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elective orthopedic lower extremity surgery patients

You may qualify if:

  • Over 65 years old
  • ASA I-III

You may not qualify if:

  • Patients under 65 years old
  • Patients contraindicated in regional anesthesia
  • Patients with local anesthetic allergy
  • Patients with injection site infection
  • Patients who do not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.

    PMID: 11149448BACKGROUND
  • Pearson AC, Gudipati CV, Labovitz AJ. Effects of aging on left ventricular structure and function. Am Heart J. 1991 Mar;121(3 Pt 1):871-5. doi: 10.1016/0002-8703(91)90201-r.

    PMID: 1825740BACKGROUND
  • Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.

    PMID: 12072670BACKGROUND
  • Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.

    PMID: 23397432BACKGROUND
  • Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.

    PMID: 16790660BACKGROUND
  • Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.

    PMID: 23055034BACKGROUND
  • Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.

    PMID: 12580205BACKGROUND

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 12, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

December 12, 2016

Record last verified: 2016-12