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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06126133
• Other study ID #: 2022-6/5
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 11, 2023
• Est. completion date: January 13, 2024

Study information

• Verified date: November 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: Korgün Ökmen, Assoc. PhD.
• Phone: +905057081021
• Email: korgunokmen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 13, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Near Infrared Spectroscopy
• Nerve Block

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Outcome

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