CompletedNot Applicable

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

Turkey (Türkiye)80 participantsStarted 2018-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Perfusion Index Following Nerve Block

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

Trial details

NCT IDNCT07507227

SponsorUniversity of Gaziantep

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-01

View on ClinicalTrials.gov More Peripheral Nerve Block trials