Clinical trial NCT06372691: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?
Official title: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult
Regional Anesthesia Morbidity
Anesthesia Injection Site
Keywords: Popliteal Approach Sciatic Nerve Block
Regional Anesthesia
Foot, Ankle and Toe Amputation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Onset Time
timeFrame: Time from the moment the block is made to the moment it starts, within the first half hour
Secondary outcomes:
measure: Block Execution Times
timeFrame: 1-10 minutes
measure: Need for Multiple Injections Owing to Insufficient Anesthesia
timeFrame: Within 24 hours
measure: Additional Rescue Analgesic
timeFrame: Within 24 hours
measure: Adverse Effects to Anesthesia
timeFrame: During the block period, within 24 hours
measure: Hemodynamic Effects Of The Block
timeFrame: 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
measure: Effects Of The Block On Heart Rate
timeFrame: 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
measure: Effects Of The Block On Peripheral Pulse Oximetry
timeFrame: 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
measure: Regression Time Of Sensory and Motor Block
timeFrame: Within 24 hours
measure: Total Block Times
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Semih Başkan
role: PRINCIPAL_INVESTIGATOR
References: