Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

Study Overview
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Brief Summary
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The purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus. After induction of general anesthesia, the leg to be operated first is decided randomly. After the operation of one leg is completed, PSNB is performed on both legs with 0.2% Ropivacaine and surgery is started on the remaining legs. When the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.

Official Title
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Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery

Conditions
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Pain, Postoperative, Preemptive Peripheral Nerve Block, Acute Pain

Intervention / Treatment
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* Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults between the ages of 20 and 80 bilateral hallux valgus surgery on the same day ASA class 1 or 2 Patients who have voluntarily agreed in writing to participate in the trial Exclusion Criteria: Patient with side effects on local anesthetics or steroids Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc. Patients with uncontrolled medical or psychiatric problem Patient does not agree to participate in the study Patients who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who underwent surgery on both feet at the same time. One foot is performed before surgery and the other is performed after surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preoperative blocked leg: group preB<br>ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision | Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine<br>* Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml<br>|
| Active Comparator: postoperative blocked leg: group postB<br>ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision | Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine<br>* Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic duration of nerve block | The difference of NRS during study time between group preB and group postB The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0: No pain, 1-3: mild pain, 4-6: Moderate pain, 7-10: severe pain, 10: worst pain imaginable. | at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of analgesic consumption between both group | The difference of usage of rescue analgesics during study time between group preB and group postB after the operation | at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1 | 
| side effect of popliteal sciatic nerve block | any other sensation except pain | at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preemptive analgic effect, popliteal sciatic nerve block, Bilateral Hallux Valgus