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

Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372691
• Other study ID #: PoplitealApproach SciaticBlock
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Ankara City Hospital Bilkent
• Contact: Aysegül Özel Erdem
• Phone: 5549777289
• Email: aysegulozell[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 809
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult
• Regional Anesthesia Morbidity

Intervention

Other:
• Subparaneural Injection (Grup S), Block
Comparison of two different methods in terms of various features
• Interneural Injection (Grup I), Block
Comparison of two different methods in terms of various features

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Block Execution Times	The time from the moment the block starts to the moment the transaction ends.	1-10 minutes
Secondary	Need for Multiple Injections Owing to Insufficient Anesthesia	How many blocks should be made.	Within 24 hours
Secondary	Additional Rescue Analgesic	Analgesic use status.	Within 24 hours
Secondary	Adverse Effects to Anesthesia	hypotension, agitation, nausea, vomiting, dizziness	During the block period, within 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Regression Time Of Sensory and Motor Block	When the block starts to come back.	Within 24 hours
Secondary	Total Block Times	How long the block took in total.	Within 24 hours