Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacain.
- Who it may be relevant to
- Registry conditions: Tibial Plateau Fractures. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial
Overview
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).
Interventions
- Drug Bupivacain
5mL 0.25% bupivacain
Primary outcome measures
- Pain Ratings from Visual Analog Scale (VAS) [Time frame: one hour, two hours, and discharge from PACU]
Secondary outcome measures (7)
- 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]
Eligibility criteria
Inclusion criteria
- Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Chicago — Chicago
Identifiers
NCT: NCT06639503 · IRB23-0930