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

NCT ID: NCT06126133

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-11

Study Completion Date

2024-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nerve Block Lumbar Plexus Near Infrared Spectroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Near İnfrared Spektroskopi (NIRS)

Peripheral oxygen saturation to be measured with NIRS device

Group Type EXPERIMENTAL

Near Infrared Spectroscopy

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Korgün Ökmen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Korgün Ökmen, Assoc. PhD.

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Korgün Ökmen, Assoc. PhD.

Role: CONTACT

+905057081021

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-6/5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.