A Phase 1 interventional study of Bupivacain in Tibial Plateau Fractures, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of Chicago · Phase 1, Interventional, and Supportive care
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.
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).
32 studies on the registry are indexed under Tibial Plateau Fractures; 9 are open to participants now.
This study's planned enrollment of 38 is below the median of 44 across 20 interventional studies indexed under Tibial Plateau Fractures.
Browse Tibial Plateau Fractures studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
Drug: Bupivacain
5mL 0.25% bupivacain
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')
Time frame: one hour, two hours, and discharge from PACU
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')
Time frame: 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.
Time frame: 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')
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 2 weeks after surgery
Plan to share: No — No plan to share individual participant data
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