Perfusion Index for Assessing Femoral and Sciatic Nerve Block Success in Lower Extremity Surgery

NCT07507227 | Completed DMC

• 1 other identifier: GAZ-PI-BLOCK-2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve blocks are increasingly used in lower extremity surgery as an alternative to general anesthesia. However, traditional methods used to assess block success, such as sensory and motor testing, are subjective, time-consuming, and dependent on patient cooperation. The perfusion index (PI), measured non-invasively using pulse oximetry, reflects peripheral perfusion changes associated with sympathetic blockade and may serve as an early indicator of block effectiveness. This study aims to evaluate whether PI can be used as an early and reliable marker for assessing the success of combined femoral and sciatic nerve block in patients undergoing elective lower extremity surgery. A total of 80 patients aged 18-65 years with ASA physical status I-III will receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block. Hemodynamic parameters and perfusion-related variables, including PI, capillary refill time, and skin temperature, will be recorded at baseline and at 5, 10, 20, and 30 minutes after block administration. The results will be compared with traditional sensory and motor block assessments to determine whether PI provides an earlier and objective assessment of block success.

Conditions

Peripheral Nerve Block

Keywords

Perfusion Index; Femoral Nerve Block; Sciatic Nerve Block; Peripheral Nerve Block; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Change in Perfusion Index Following Nerve Block

  Perfusion index values measured at predefined time intervals after combined femoral and sciatic nerve block and compared with baseline and contralateral limb values.

  Baseline, 5, 10, 20, and 30 minutes after block administration

Study Arms (1)

Combined Femoral and Sciatic Nerve Block

EXPERIMENTAL

All participants receive ultrasound- and nerve stimulator-guided combined femoral and sciatic nerve block prior to lower extremity surgery.

Procedure: Combined Femoral and Sciatic Nerve Block

Interventions

Combined Femoral and Sciatic Nerve Block PROCEDURE

Ultrasound- and nerve stimulator-guided femoral and sciatic nerve block performed using a mixture of bupivacaine and lidocaine for anesthesia in lower extremity surgery.

Combined Femoral and Sciatic Nerve Block

Eligibility Criteria

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

You may qualify if:

• Patients aged between 18 and 65 years
• ASA physical status I-III
• Scheduled for elective lower extremity surgery
• Patients undergoing combined femoral and sciatic nerve block
• Ability to provide informed consent

You may not qualify if:

• Patient refusal
• Infection at the injection site
• Known allergy to local anesthetic agents
• Coagulopathy or bleeding disorders
• Pre-existing neurological deficits in the lower extremities
• Severe systemic disease (ASA IV and above)

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Faculty of Medicine

Gaziantep, Turkey (Türkiye)

Location

Study Officials

• Berna Kaya Uğur

  Gaziantep University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a single-group interventional study in which all participants receive combined femoral and sciatic nerve block. Perfusion index and conventional block assessment methods are measured and compared over time to evaluate block success.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: June 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: January 31, 2019
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

TU (1)