Adult, Anesthesia Injection Site, Regional Anesthesia Morbidity
Conditions
Keywords
Popliteal Approach Sciatic Nerve Block, Regional Anesthesia, Foot, Ankle and Toe Amputation
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.
Interventions
OTHERSubparaneural Injection (Grup S), Block
Comparison of two different methods in terms of various features
OTHERInterneural Injection (Grup I), Block
Comparison of two different methods in terms of various features
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adverse Effects to Anesthesia | During the block period, within 24 hours | hypotension, agitation, nausea, vomiting, dizziness |
| 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 |
| Block Execution Times | 1-10 minutes | The time from the moment the block starts to the moment the transaction ends. |
| 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 |
| Regression Time Of Sensory and Motor Block | Within 24 hours | When the block starts to come back. |
| Total Block Times | Within 24 hours | How long the block took in total. |
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed