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

Not Applicable

Recruiting

• Conditions: Adult; Anesthesia Injection Site; Regional Anesthesia Morbidity

• Registration Number: NCT06372691
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Study Start: 2024-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 809

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Onset Time	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 Outcome Measures

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

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey