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Completed

NCT Number: NCT06372691

How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?

The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06000, Turkey (Türkiye)

About this study

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.

Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.

Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and over
  • Planned foot, ankle or toe amputation
  • ASA III-IV risk group
  • Patients who agreed to be included in the study

Exclusion criteria

  • People with neurological and psychiatric diseases
  • Using opioids or another analgesic for chronic pain
  • Allergic to local anesthetics
  • Pregnant or breastfeeding
  • Those with infection or sepsis in the application area
  • Patients who did not agree to be included in the study

Treatment and study plan

Subparaneural Injection (Grup S), Block

Other

Comparison of two different methods in terms of various features

Interneural Injection (Grup I), Block

Other

Comparison of two different methods in terms of various features

Primary outcomes

  1. Onset Time

    Time frame: Time from the moment the block is made to the moment it starts, within the first half hour

    Onset time will be defined as the moment when it is determined that the block is successful.

Secondary outcomes

  1. Block Execution Times

    Time frame: 1-10 minutes

    The time from the moment the block starts to the moment the transaction ends.

  2. Need for Multiple Injections Owing to Insufficient Anesthesia

    Time frame: Within 24 hours

    How many blocks should be made.

  3. Additional Rescue Analgesic

    Time frame: Within 24 hours

    Analgesic use status.

  4. Adverse Effects to Anesthesia

    Time frame: During the block period, within 24 hours

    hypotension, agitation, nausea, vomiting, dizziness

  5. Hemodynamic Effects Of The Block

    Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes

    Noninvasive systolic and diastolic blood pressure

  6. Effects Of The Block On Heart Rate

    Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes

    Heart rate

  7. Effects Of The Block On Peripheral Pulse Oximetry

    Time frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes

    Peripheral pulse oximetry

  8. Regression Time Of Sensory and Motor Block

    Time frame: Within 24 hours

    When the block starts to come back.

  9. Total Block Times

    Time frame: Within 24 hours

    How long the block took in total.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2024
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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