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

NCT06372691 | Completed

• 1 other identifier: PoplitealApproach SciaticBlock
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult; Regional Anesthesia Morbidity; Anesthesia Injection Site

Keywords

Popliteal Approach Sciatic Nerve Block; Regional Anesthesia; Foot, Ankle and Toe Amputation

Outcome Measures

Primary Outcomes (1)

• Onset Time

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

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

Secondary Outcomes (9)

• Block Execution Times

  1-10 minutes

• Need for Multiple Injections Owing to Insufficient Anesthesia

  Within 24 hours

• Additional Rescue Analgesic

  Within 24 hours

• Adverse Effects to Anesthesia

  During the block period, within 24 hours

• Hemodynamic Effects Of The Block

  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

Study Arms (2)

Subparaneural Injection (Group S)

ACTIVE COMPARATOR

The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions,we will be positioned it transversely in the popliteal fossa.After visualizing the artery,its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate,they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the subparaneural area in Group S.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20G,12mm block needle.

Other: Subparaneural Injection (Grup S), Block

Interneural Injection (Group I)

ACTIVE COMPARATOR

The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions, we will be positioned it transversely in the popliteal fossa.After visualizing the artery, its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate, they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the interneural area in Group I.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20 G, 12mm block needle.

Other: Interneural Injection (Grup I), Block

Interventions

Subparaneural Injection (Grup S), Block OTHER

Comparison of two different methods in terms of various features

Subparaneural Injection (Group S)

Interneural Injection (Grup I), Block OTHER

Comparison of two different methods in terms of various features

Interneural Injection (Group I)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Semih Başkan

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doç. Prof. Dr.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2024-09

Locations

TU (1)