Anterior Cruciate Ligament RuptureNCT06048848
FNB in ACL Recon Under GA
A study testing Sono-guided injection, Ropivacaine injection and Saline injection in people with Anterior Cruciate Ligament Rupture 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 anterior cruciate ligament reconstruction under general anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, 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 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.
Who cannot join
- who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral 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. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
TaeYeong Kim, 82 33 240 5198, kty2991@gmail.com
Jung-Taek Hwang, MD, PhD
About this study
Official title: Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under General Anesthesia: A Randomized Controlled Trial
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under general 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 anterior cruciate ligament rupture 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 general anesthesia for arthroscopic anterior cruciate ligament reconstruction. 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.
- Being tested
- Sono-guided injection, Ropivacaine injection, Saline injection
- Medical subject headings
- Anterior Cruciate Ligament Injuries
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 general anesthesia, patients will be injected around femoral nerve using ultrasonography.
Ropivacaine injectionDrug
After general anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
Saline injectionDrug
After general anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
| Study group | Role | What they receive |
|---|---|---|
| FNB | Experimental | sono-guided injection with 20ml ropivacaine Receives: Procedure: Sono-guided injection; Drug: Ropivacaine injection |
| no FNB | Placebo comparator | sono-guided 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) 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 2028 (estimated)
- Study completion18 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- NCT06048848
- Sponsor's protocol ID
- 2023-07-021-001
- 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 Anterior Cruciate Reconstruction Under General Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06048848
- Acronym / sponsor ID
- 2023-07-021-001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (estimated)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 18 Sep 2028 (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 anterior cruciate ligament reconstruction under general 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 anterior cruciate ligament rupture 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 general anesthesia for arthroscopic anterior cruciate ligament reconstruction. 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 injection with 20ml ropivacaine |
| no FNB | Placebo comparator | Procedure: Sono-guided injection, Drug: Saline injectionsono-guided injection with 20ml 0.9% saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.
Key exclusion criteria (5 listed)
- who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral 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 general anesthesia, patients will be injected around femoral nerve using ultrasonography. | Procedure or surgery | FNB, no FNB |
| Ropivacaine injectionAfter general anesthesia, patients will be injected 20ml ropivacaine around femoral nerve. | Drug | FNB |
| Saline injectionAfter general 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
This study is still under way. Results are not available in the source record yet.
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.
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 Anterior Cruciate Ligament Rupture 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 1 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: opening soon, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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.