- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03414593
Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Songpa-gu
-
Seoul, Songpa-gu, Korea, Republic of, 05505
- Asan Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: preoperative blocked leg: group preB
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision
|
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
|
Active Comparator: postoperative blocked leg: group postB
ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision
|
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic duration of nerve block
Time Frame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
|
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
Time Frame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
|
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
Time Frame: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-0856
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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