Tibial Plateau FractureNCT04314570
Saphenous Nerve Block After Tibial Plateau ORIF
A study testing Saphenous Nerve Block with Ropivacaine Treatment in people with Tibial Plateau Fracture and Pain, Postoperative, run by Stanford University.
Trial summary
Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Plateau Fracture, Pain, Postoperative
- What is being tested?
- Saphenous Nerve Block with Ropivacaine Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tibial plateau fracture presenting for ORIF
- Age greater than or equal to 18 years
Who cannot join
- Other concomitant life-threatening injuries
- History of chronic pain prior to tibial plateau ORIF
- Age <18 years old
- Pregnancy
- Any condition impairing patient's ability to consent to participation in study
- Existing condition contraindicating a nerve block
- Non-English Speaking
About this study
Official title: Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Our study aims to evaluate the effectiveness of saphenous nerve block for pain management after surgical repair of a tibial plateau fracture. Based on cadaver studies and our clinical experience, we suspect that the saphenous nerve contributes to pain sensations of the tibial plateau and will not mask the pain from a compartment syndrome. In summary, while saphenous nerve block represents a safe option after tibial plateau open reduction internal fixation (ORIF), we aim to evaluate its effectiveness in this patient population.
- Conditions
- Tibial Plateau Fracture, Pain, Postoperative
- Being tested
- Saphenous Nerve Block with Ropivacaine Treatment, Saphenous Nerve Block with Saline Control
- Medical subject headings
- Tibial Plateau Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous Nerve Block with Ropivacaine TreatmentProcedure or surgery
Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive ropivacaine through the catheter from the start of the nerve block.
Saphenous Nerve Block with Saline ControlProcedure or surgery
Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Treatment | Experimental | After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Ropivacaine through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol. Receives: Procedure: Saphenous Nerve Block with Ropivacaine Treatment |
| Saline Control | Placebo comparator | After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol. Receives: Procedure: Saphenous Nerve Block with Saline Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain scores on a scale from 0 to 10 will be collected by the research staff for 1 hour following the post-operative block. Pain scores will also be collected by the nurses throughout the patient's stay.
Measured: Through hospital stay, an average of 3 days
Opioid requirements
Opioid medications recorded in opioid morphine equivalents will be recorded by the research staff for the first hour following the post-operative nerve block. Opioid medications will be collected by the nurses throughout the patient's stay.
Measured: Through hospital stay, an average of 3 days
Length of Stay
The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.
Measured: Through hospital stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Study personnel planning to conduct the study departed Stanford
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FractureStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Louis Horn, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314570
- Sponsor's protocol ID
- 31480
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2020
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
- ClinicalTrials.gov ID
- NCT04314570
- Acronym / sponsor ID
- 31480
- Conditions
- Tibial Plateau Fracture, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study personnel planning to conduct the study departed Stanford
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 19 Mar 2020 (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.
Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Our study aims to evaluate the effectiveness of saphenous nerve block for pain management after surgical repair of a tibial plateau fracture. Based on cadaver studies and our clinical experience, we suspect that the saphenous nerve contributes to pain sensations of the tibial plateau and will not mask the pain from a compartment syndrome. In summary, while saphenous nerve block represents a safe option after tibial plateau open reduction internal fixation (ORIF), we aim to evaluate its effectiveness in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Treatment | Experimental | Procedure: Saphenous Nerve Block with Ropivacaine TreatmentAfter the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Ropivacaine through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol. |
| Saline Control | Placebo comparator | Procedure: Saphenous Nerve Block with Saline ControlAfter the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tibial plateau fracture presenting for ORIF
- Age greater than or equal to 18 years
Key exclusion criteria (7 listed)
- Other concomitant life-threatening injuries
- History of chronic pain prior to tibial plateau ORIF
- Age <18 years old
- Pregnancy
- Any condition impairing patient's ability to consent to participation in study
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 |
|---|---|---|
| Saphenous Nerve Block with Ropivacaine TreatmentRegional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive ropivacaine through the catheter from the start of the nerve block. | Procedure or surgery | Ropivacaine Treatment |
| Saphenous Nerve Block with Saline ControlRegional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol. | Procedure or surgery | Saline Control |
Primary outcome
Pain Scores
Time frame: Through hospital stay, an average of 3 days
Pain scores on a scale from 0 to 10 will be collected by the research staff for 1 hour following the post-operative block. Pain scores will also be collected by the nurses throughout the patient's stay.
Opioid requirements
Time frame: Through hospital stay, an average of 3 days
Opioid medications recorded in opioid morphine equivalents will be recorded by the research staff for the first hour following the post-operative nerve block. Opioid medications will be collected by the nurses throughout the patient's stay.
Length of Stay
Time frame: Through hospital stay, an average of 3 days
The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Saphenous Nerve Block with Ropivacaine Treatment in people with Tibial Plateau Fracture and Pain, Postoperative, run by Stanford University.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain Scores (time frame: Through hospital stay, an average of 3 days). The study lists 3 primary outcomes in all. 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 1 Jul 2026.