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

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

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

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity; Adult; Anesthesia Injection Site
• Intervention / Treatment: Other: Subparaneural Injection (Grup S), Block; Other: Interneural Injection (Grup I), Block

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06000
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Subparaneural Injection (Grup S), Block; Comparison of two different methods in terms of various features
Active Comparator: 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.	Other: Interneural Injection (Grup I), Block; Comparison of two different methods in terms of various features

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block Execution Times	The time from the moment the block starts to the moment the transaction ends.	1-10 minutes
Need for Multiple Injections Owing to Insufficient Anesthesia	How many blocks should be made.	Within 24 hours
Additional Rescue Analgesic	Analgesic use status.	Within 24 hours
Adverse Effects to Anesthesia	hypotension, agitation, nausea, vomiting, dizziness	During the block period, within 24 hours
Hemodynamic Effects Of The Block	Noninvasive systolic and diastolic blood pressure	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
Effects Of The Block On Heart Rate	Heart rate	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
Effects Of The Block On Peripheral Pulse Oximetry	Peripheral pulse oximetry	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
Regression Time Of Sensory and Motor Block	When the block starts to come back.	Within 24 hours
Total Block Times	How long the block took in total.	Within 24 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Semih Başkan, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Popliteal Approach Sciatic Nerve Block; Foot, Ankle and Toe Amputation
• Other Study ID Numbers: PoplitealApproach SciaticBlock

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No