Pain, PostoperativeNCT03414593
Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
A study testing Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine in people with Pain, Postoperative and Preemptive Peripheral Nerve Block, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain, Postoperative, Preemptive Peripheral Nerve Block, Acute Pain
- What is being tested?
- Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine
- Keywords
- preemptive analgic effect, popliteal sciatic nerve block, Bilateral Hallux Valgus
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaineDrug
Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
| Study group | Role | What they receive |
|---|---|---|
| preoperative blocked leg: group preB | Experimental | ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision Receives: Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine |
| postoperative blocked leg: group postB | Active comparator | ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision Receives: Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
Secondary outcomes (2)
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
Measured: 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
Measured: at 0, 0.5, 1, 4, 8, 12 hours after operation. And AM 9 and PM 5 of POD (Post Operative Day) 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start2 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hyuk Lee, Asan Medical Center
- Investigators
- JongHyuk Lee, md, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414593
- Sponsor's protocol ID
- 2017-0856
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single Blind Trial of Preemptive Analgesic Effects of Popliteal Sciatic Nerve Block in Patients With Bilateral Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT03414593
- Acronym / sponsor ID
- 2017-0856
- Keywords
- preemptive analgic effect, popliteal sciatic nerve block, Bilateral Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| preoperative blocked leg: group preB | Experimental | Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaineultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml Before surgical incision |
| postoperative blocked leg: group postB | Active comparator | Drug: Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaineultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml After surgical incision |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaineUltrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml | Drug | postoperative blocked leg: group postB, preoperative blocked leg: group preB |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JongHyuk Lee, md principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine in people with Pain, Postoperative and Preemptive Peripheral Nerve Block, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.