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

NCT ID: NCT06372691

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-04-01

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.

Detailed Description

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.

Conditions

Adult; Regional Anesthesia Morbidity; Anesthesia Injection Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subparaneural Injection (Group S)

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.

Group Type: ACTIVE_COMPARATOR

Subparaneural Injection (Grup S), Block

Intervention Type: OTHER

Comparison of two different methods in terms of various features

Interneural Injection (Group I)

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.

Group Type: ACTIVE_COMPARATOR

Interneural Injection (Grup I), Block

Intervention Type: OTHER

Comparison of two different methods in terms of various features

Interventions

Subparaneural Injection (Grup S), Block

Comparison of two different methods in terms of various features

Intervention Type: OTHER

Interneural Injection (Grup I), Block

Comparison of two different methods in terms of various features

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

semih başkan

Doç. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semih Başkan

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PoplitealApproach SciaticBlock

Identifier Type: -

Identifier Source: org_study_id