Meniscus TearNCT06048341
FNB in Meniscal Tear Under SA
A study testing Sono-guided injection, Ropivacaine injection and Saline injection in people with Meniscus Tear and Femoral Nerve Block, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Meniscus Tear, Femoral Nerve Block
- What is being tested?
- Sono-guided injection, Ropivacaine injection and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2023to 18 Sep 2026
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear.
- who have previously undergone surgical treatment within the knee joint.
- who have declined to participate in the research.
- where medical, surgical, or anesthetic complications occurred during surgery.
- other cases deemed necessary by the researchers.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Meniscal Tear Under Spinal Anesthesia: A Randomized Controlled Trial
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia
Read the detailed description
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic meniscal surgery. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.
- Conditions
- Meniscus Tear, Femoral Nerve Block
- Being tested
- Sono-guided injection, Ropivacaine injection, Saline injection
- Keywords
- Meniscus Tear, Femoral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono-guided injectionProcedure or surgery
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.
Ropivacaine injectionDrug
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
Saline injectionDrug
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
| Study group | Role | What they receive |
|---|---|---|
| FNB | Experimental | sono-guided femoral nerve injection with 20ml ropivacaine Receives: Procedure: Sono-guided injection; Drug: Ropivacaine injection |
| No FNB | Placebo comparator | sono-guided femoral nerve injection with 20ml 0.9% saline Receives: Procedure: Sono-guided injection; Drug: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain after 24hours
VAS (Visual analog scale) measured 24 hours after operation
- the unabbreviated scale title: The visual analog scale
- the minimum and maximum values: 0, 10
- higher scores mean a worse outcome.
Measured: 24hours
Secondary outcomes (1)
postoperative pain after 1, 3, 6, 12, 18, 48 hours
VAS (Visual analog scale) score measured 1, 3, 6, 12, 18, 48 hours after operation
- the unabbreviated scale title: The visual analog scale
- the minimum and maximum values: 0, 10
- higher scores mean a worse outcome.
Measured: 1, 3, 6, 12, 18, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Sep 2023 (estimated)
- Primary completion18 Sep 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048341
- Sponsor's protocol ID
- 2023-07-020-001
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Meniscal Tear Under Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06048341
- Acronym / sponsor ID
- 2023-07-020-001
- Conditions
- Meniscus Tear, Femoral Nerve Block
- Keywords
- Meniscus Tear, Femoral Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (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 investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia
Detailed description
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic meniscal surgery. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNB | Experimental | Procedure: Sono-guided injection, Drug: Ropivacaine injectionsono-guided femoral nerve injection with 20ml ropivacaine |
| No FNB | Placebo comparator | Procedure: Sono-guided injection, Drug: Saline injectionsono-guided femoral nerve injection with 20ml 0.9% saline |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear.
- who have previously undergone surgical treatment within the knee joint.
- who have declined to participate in the research.
- where medical, surgical, or anesthetic complications occurred during surgery.
- other cases deemed necessary by the researchers.
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 |
|---|---|---|
| Sono-guided injectionAfter spinal anesthesia, patients will be injected around femoral nerve using ultrasonography. | Procedure or surgery | FNB, No FNB |
| Ropivacaine injectionAfter spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve. | Drug | FNB |
| Saline injectionAfter spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve. | Drug | No FNB |
Primary outcome
postoperative pain after 24hours
Time frame: 24hours
VAS (Visual analog scale) measured 24 hours after operation * the unabbreviated scale title: The visual analog scale * the minimum and maximum values: 0, 10 * higher scores mean a worse outcome.
1 secondary outcome
postoperative pain after 1, 3, 6, 12, 18, 48 hours
Time frame: 1, 3, 6, 12, 18, 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sono-guided injection, Ropivacaine injection and Saline injection in people with Meniscus Tear and Femoral Nerve Block, run by Chuncheon Sacred Heart Hospital 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 0 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 22 Sep 2023. 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. Some participants in this study may receive a placebo. 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?
postoperative pain after 24hours (time frame: 24hours). 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 22 Sep 2023.