Evaluation of Lumbar Plexus Block Success With Near Infrared Spectroscopy (NIRS)

November 10, 2023 updated by: Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Near Infrared Spectroscopy (NIRS) Evaluation of Lumbar Plexus Block Success for Lower Extremity Orthopedic Surgery

Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient.

Near Infrared Spectroscopy (NIRS) measures the differential absorption and reflection of near infrared light transmitted by human tissues, providing a tissue-oxygen saturation index. Modern NIRS-based instruments use multiple detectors to filter spectroscopy data from skin structures to detect subcutaneous tissue oxygenation.

Successful regional anesthesia results in decreased sympathetic activity within the distribution of blocked nerves. Regional oxygen saturation (rSO2) has been shown to increase in innervated areas after sympathetic block.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to show whether the success of lumbar plexus block applied in lower extremity orthopedic surgeries can be evaluated by Near Infrared Spectroscopy (NIRS), which is used to measure tissue oxygenation.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-90 years old
  • femoral neck fracture,
  • femoral shaft fracture,
  • hip replacement surgery
  • who will undergo velumbar plexus block will be included in the study.

Exclusion Criteria:

  • BMI>40 kg/m2
  • infection in the block area
  • peripheral neuropathy,
  • hemoglobinopathy
  • peripheral vascular disease
  • allergy to local anesthetics
  • patients with contraindications for lumbar plexus block

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Near İnfrared Spektroskopi (NIRS)
Peripheral oxygen saturation to be measured with NIRS device
Device: Near Infrared Spectroscopy
Two NIRS probes will be attached to the extremity to be operated on and to the other lower extremity on the opposite side, at a level approximately coinciding with the midline above the quandriceps femoris muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rso2
Time Frame: 40 minutes
The regional oxymetry probe will be placed in the the quandriceps femoris muscle, one on the extremity to be operated on and the other on the opposite lower extremity.
40 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory block level
Time Frame: 40 minutes
The sensory block level will be realised by cold testing at 10 minute intervals after applying the block.
40 minutes
blood pressure values
Time Frame: 40 minutes
systolic, diastolic and mean blood pressure values will be recorded non-invasively in mmhg.
40 minutes
so2
Time Frame: 40 minutes
fingertip SO2 measured by pulse oximetry
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Korgün Ökmen, Assoc. PhD., University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

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)

November 11, 2023

Primary Completion (Estimated)

December 25, 2023

Study Completion (Estimated)

January 13, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-6/5

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.

Clinical Trials on Nerve Block

Clinical Trials on Near Infrared Spectroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe