- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758245
Comparative Efficacy of Sciatic and Femoral Blocks in Ankle Surgery
Comparison of Anesthetic and Postoperative Analgesic Efficacy of Femoral and Popliteal Sciatic Block Application With Femoral and Anterior Sciatic Block Application in Ankle Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
The sciatic nerve, which arises from the sacral plexus, is the largest nerve in the body. It originates in the posterior region of the thigh in the lumbosacral area and is formed from the anterior branches of spinal nerves from L4 to S3 within the pelvis. It exits the pelvis through the greater sciatic foramen directly below the piriformis and then progresses towards the posterior compartment of the thigh, where it usually divides into the common peroneal nerve and the tibial nerve at the upper corner of the popliteal fossa. Sciatic nerve blocks provide both analgesia and anesthesia in surgeries below the knee, knee surgeries involving the posterior compartment, and foot and ankle surgeries. They can be used alone or in combination with an ipsilateral lumbar plexus block or femoral nerve block to provide surgical anesthesia or analgesia for the entire lower extremity.
Various approaches have been described to perform sciatic nerve block, including anterior and popliteal approaches. The anterior approach to the sciatic nerve can be performed as easily and successfully under ultrasound guidance as the popliteal approach. The anterior approach is advantageous when combined with a femoral nerve block, as it is performed with the patient in the supine position. Due to ease of application and high success rates, peripheral blocks have begun to be incorporated into anesthesia and postoperative analgesia strategies in ankle surgeries. The use of ultrasonography plays a crucial role in increasing the success rate of the block and reducing potential complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Gaziosmanpaşa Training and Research Hospital
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Gaziosmanpasa
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Istanbul, Gaziosmanpasa, Turkey (Türkiye), 34255
- Gaziosmanpasa Training and Research Hospital, Istanbul, 34000
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
- Inclusion Criteria:
- 18-65 years of age
- American Society of Anesthesiologists physical statusⅠ-II
Exclusion Criteria:
- Pregnant
- Neuromuscular disease
- Peripheral neuropathy
- Coagulation disorders
- Allergy to local anesthetics
- Infection at the site where the nerve block will be applied
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Femoral-Anterior sciatic block group
First, in the supine position, the USG probe is placed below the inguinal crease.
The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle.
Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied.
Patellar movement is observed due to quadriceps muscle contraction upon needle placement.
After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament.
After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz.
Using an in-plane technique, the block needle was advanced.
Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test.
|
First, in the supine position, the USG probe is placed below the inguinal crease.
The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle.
Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied.
Patellar movement is observed due to quadriceps muscle contraction upon needle placement.
After a negative aspiration test, 20 ml of local anesthetic is injected.For the anterior sciatic block, while the patient was in the supine position, a convex ultrasound (USG) probe was placed transversely approximately 10 cm distal to the inguinal ligament.
After visualizing the sciatic nerve as a hyperechoic flat structure, the nerve stimulator was set to 1-1.5 mA, 0.1 ms, and 1 Hz.
Using an in-plane technique, the block needle was advanced.
Upon reaching the sciatic nerve, when contractions in the calf, foot, or big toe continued at a current of 0.3-0.5 mA, 20 ml of 0.5% bupivacaine was administered following a negative aspiration test.
|
|
Active Comparator: Femoral-popliteal sciatic block group
First, in the supine position, the USG probe is placed below the inguinal crease.
The femoral nerve is located lateral to the femoral artery, above the iliopsoas muscle.
Once the needle tip reaches the nerve, simultaneous nerve stimulation is applied.
Patellar movement is observed due to quadriceps muscle contraction upon needle placement.
After a negative aspiration test, 20 ml of local anesthetic is injected.The ultrasound probe is placed transversely at the popliteal crease.
The first structure seen is the popliteal artery.
Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure.
After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease.
The needle is advanced using an in-plane technique.
After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test.
|
The ultrasound probe is placed transversely at the popliteal crease.
The first structure seen is the popliteal artery.
Just above and lateral to the artery, the tibial nerve appears as a hyperechoic, oval, and round structure.
After identifying the tibial and peroneal nerves, the probe is moved proximally, and it is observed that the nerves join about 5-10 cm above the popliteal crease.
The needle is advanced using an in-plane technique.
After obtaining the first sciatic nerve stimulation, 20 cc of 0.5% bupivacaine is injected following a negative aspiration test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale values
Time Frame: at 1st, 4th,8th 12th ,24th and 48th hours after the surgery
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Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
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at 1st, 4th,8th 12th ,24th and 48th hours after the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Total amount of opioid requirements
Time Frame: within 48 hours after the surgery
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The total tramadol use of the patients in 48 hours will be recorded.
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within 48 hours after the surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Döndü GENÇ MORALAR, MD, Gaziosmanpasa Research and Training Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAZİOSMANPASATREHTAa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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