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

NCT06126133 | Unknown

• 1 other identifier: 2022-6/5
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nerve Block; Lumbar Plexus; Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• rso2

  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 Outcomes (3)

• sensory block level

  40 minutes

• blood pressure values

  40 minutes

• so2

  40 minutes

Study Arms (1)

Near İnfrared Spektroskopi (NIRS)

EXPERIMENTAL

Peripheral oxygen saturation to be measured with NIRS device

Device: Near Infrared Spectroscopy

Interventions

Near Infrared Spectroscopy 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.

Near İnfrared Spektroskopi (NIRS)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Korgün Ökmen, Assoc. PhD.

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Korgün Ökmen, Assoc. PhD.

CONTACT

+905057081021; korgunokmen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: November 11, 2023
• Primary Completion: December 25, 2023
• Study Completion: January 13, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11