Tibial Plateau FracturesPhase 1NCT06639503
Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau
A Phase 1 study testing Bupivacain in people with Tibial Plateau Fractures, run by University of Chicago at 1 site in United States.
Trial summary
The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 14 Oct 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture
Who cannot join
- Subjects younger than 18
- Polytraumatized Subjects
- Subjects with pathologic fractures
- Subjects with tibial plateau fractures treated nonoperatively
- Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
- Subjects with open fractures
Show all 18Show fewer
- Subjects with fracture-dislocations
- Subjects with active or history of anxiety
- Subjects with visual analog scale anxiety score ≥ 7 measured preoperatively
- Subjects with chronic pain syndromes
- Subjects with chronic opioid use
- Subjects with illicit drug use disorder
- Subjects with alcohol abuse disorder
- Subjects with kidney disease precluding use of ketorolac
- Subjects with liver disease precluding the use of acetaminophen
- Subjects with allergy to acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opiates or local anesthesia
- Subjects with inability to provide a visual analog scale score postoperatively
- Subjects with contraindications to receiving peripheral nerve blocks, including relevant neurologic deficits, active infection at sites of injections - re-operation at the same site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Anthony Christiano, MD, anthony.christiano@bsd.uchicago.edu
Anthony Christiano, MD
About this study
Official title: Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial
The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.
Read the detailed description
The investigators are conducting this research study to find better ways of treating pain following knee surgery like the one the participant will be having. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control. This type of nerve block is commonly used to treat other knee pains, like that associated with arthritis, after knee replacements, and after repairs of the knee ligaments; however, it is considered experimental in your case, as its effects (good or bad) are unknown in the type of knee surgery the participant are undergoing.
The investigators plan is to decide at random, like the flip of a coin, whether to give numbing medication (0.25% bupivacaine) around the incision like the investigators normally would or give it instead to block the pain sensors around the knee. The participant would get medication either at the incision (shin) or the knee, depending on which arm the participant are in (research). The participant will also be given pain medication pills by your surgeon as part of the participant normal postoperative care (not research).
- Conditions
- Tibial Plateau Fractures
- Being tested
- Bupivacain
- Keywords
- peri-incisional local anesthesia, genicular nerve block, Tibial Plateau Fractures, open reduction internal fixation
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
5mL 0.25% bupivacain
| Study group | Role | What they receive |
|---|---|---|
| Peri-incisional local anesthesia | No intervention | subjects randomized to peri-incisional local anesthesia administration will receive an injection of 25 ml of 0.25% bupivacaine across all incisions at the time of wound closure (standard of care) |
| Genicular nerve blockade | Experimental | Subjects randomized to genicular nerve block will receive a fluoroscopic guided injection of 5 ml of 0.25% bupivacaine at the described locations of the superolateral genicular nerve, super medial genicular nerve, inferomedial genicular nerve, recurrent fibular nerve, and infrapatellar branch of the saphenous nerve under fluoroscopic guidance at the time of wound closure Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Ratings from Visual Analog Scale (VAS)
To determine if genicular nerve blockade after open reduction internal fixation of tibial plateau fractures compared to standard care of peri-incisional local anesthetic leads to decreased pain as measured by visual analog scale at one hour postoperatively, two hours postoperatively, and at Post Anesthesia Care Unit (PACU) discharge. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: one hour, two hours, and discharge from PACU
Secondary outcomes (7)
Comparing blocks
To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using they Visual analog (VAS) scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: one hour after surgery, 2 hours after surgery, and discharge from PACU
Block effect on range of motion
To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on postoperative function as assessed by postoperative knee range of motion at time of Post Anesthesia Care Unit (PACU) discharge.
Measured: PACU discharge
VAS score daily first three days after surgery
To determine the effect of genicular nerve block compared to standard peri-incisional local anesthetic on pain control for the first three days after surgery as measured by the visual analog scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: daily for three days after surgery
Brief pain inventory (short scale) daily first three days after surgery
To determine the effect of genicular nerve block compared to standard peri-incisional local anesthetic on pain control for the first three days after surgery as measured by the Brief pain inventory (short scale). the brief pain inventory (Short form) uses a 0 to 10 numeric rating scales for item rating.
1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain
Measured: daily first three days after surgery
effect of genicular nerve blockade compared to standard peri-incisional local anesthetic
To determine the effect of genicular nerve blockade compared to standard peri-incisional local anesthetic on opiate use as determined by the number of prescription opiate pain pills remaining at 2 weeks post surgery.
Measured: 2 weeks post surgery
Comparing blocks
To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using the Brief pain inventory (short form). the brief pain inventory (Short form) uses a 0 to 10 numeric rating scales for item rating.
1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain
Measured: daily first three days after surgery
Comparing blocks
To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using opiate pill counts.
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subgroups will be determined using equal block randomization. Blocks will be set to groups of 4 with each block of 4 comprising 2 peri-incisional local anesthesia and 2 genicular nerve blockade opaque envelopes in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Christiano, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639503
- Sponsor's protocol ID
- IRB23-0930
- Status last verified
- Feb 2026
- First submitted
- 9 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06639503
- Acronym / sponsor ID
- IRB23-0930
- Conditions
- Tibial Plateau Fractures
- Keywords
- peri-incisional local anesthesia, genicular nerve block, Tibial Plateau Fractures, open reduction internal fixation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (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 are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.
Detailed description
The investigators are conducting this research study to find better ways of treating pain following knee surgery like the one the participant will be having. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control. This type of nerve block is commonly used to treat other knee pains, like that associated with arthritis, after knee replacements, and after repairs of the knee ligaments; however, it is considered experimental in your case, as its effects (good or bad) are unknown in the type of knee surgery the participant are undergoing.
The investigators plan is to decide at random, like the flip of a coin, whether to give numbing medication (0.25% bupivacaine) around the incision like the investigators normally would or give it instead to block the pain sensors around the knee. The participant would get medication either at the incision (shin) or the knee, depending on which arm the participant are in (research). The participant will also be given pain medication pills by your surgeon as part of the participant normal postoperative care (not research).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subgroups will be determined using equal block randomization. Blocks will be set to groups of 4 with each block of 4 comprising 2 peri-incisional local anesthesia and 2 genicular nerve blockade opaque envelopes in random order.
| Arm | Type | Receives |
|---|---|---|
| Peri-incisional local anesthesia | No intervention | –subjects randomized to peri-incisional local anesthesia administration will receive an injection of 25 ml of 0.25% bupivacaine across all incisions at the time of wound closure (standard of care) |
| Genicular nerve blockade | Experimental | Drug: BupivacainSubjects randomized to genicular nerve block will receive a fluoroscopic guided injection of 5 ml of 0.25% bupivacaine at the described locations of the superolateral genicular nerve, super medial genicular nerve, inferomedial genicular nerve, recurrent fibular nerve, and infrapatellar branch of the saphenous nerve under fluoroscopic guidance at the time of wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture
Key exclusion criteria (18 listed)
- Subjects younger than 18
- Polytraumatized Subjects
- Subjects with pathologic fractures
- Subjects with tibial plateau fractures treated nonoperatively
- Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
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 |
|---|---|---|
| Bupivacain5mL 0.25% bupivacain | Drug | Genicular nerve blockade |
Primary outcome
Pain Ratings from Visual Analog Scale (VAS)
Time frame: one hour, two hours, and discharge from PACU
To determine if genicular nerve blockade after open reduction internal fixation of tibial plateau fractures compared to standard care of peri-incisional local anesthetic leads to decreased pain as measured by visual analog scale at one hour postoperatively, two hours postoperatively, and at Post Anesthesia Care Unit (PACU) discharge. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
7 secondary outcomes
Comparing blocks
Time frame: one hour after surgery, 2 hours after surgery, and discharge from PACU
Block effect on range of motion
Time frame: PACU discharge
VAS score daily first three days after surgery
Time frame: daily for three days after surgery
Brief pain inventory (short scale) daily first three days after surgery
Time frame: daily first three days after surgery
effect of genicular nerve blockade compared to standard peri-incisional local anesthetic
Time frame: 2 weeks post surgery
Comparing blocks
Time frame: daily first three days after surgery
Comparing blocks
Time frame: 2 weeks after surgery
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 5 Feb 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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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.
Anthony Christiano, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacain in people with Tibial Plateau Fractures, run by University of Chicago at 1 site in United States.
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 18 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Anthony Christiano, MD (773-834-3531, anthony.christiano@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Ratings from Visual Analog Scale (VAS) (time frame: one hour, two hours, and discharge from PACU). 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 5 Feb 2026.