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The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subparaneural Injection (Group S) | Active Comparator | 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. |
|
| Interneural Injection (Group I) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subparaneural Injection (Grup S), Block | Other | Comparison of two different methods in terms of various features |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semih Başkan | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Çankaya | 06000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003766 | Dental Occlusion |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| Interneural Injection (Grup I), Block | Other | Comparison of two different methods in terms of various features |
|
| 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 |