Clinical trial NCT06639503: Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau
Official title: Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Tibial Plateau Fractures
Keywords: peri-incisional local anesthesia
genicular nerve block
Tibial Plateau Fractures
open reduction internal fixation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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).

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

Primary outcomes:
measure: Pain Ratings from Visual Analog Scale (VAS)
timeFrame: one hour, two hours, and discharge from PACU
Secondary outcomes:
measure: Comparing blocks
timeFrame: one hour after surgery, 2 hours after surgery, and discharge from PACU
measure: Block effect on range of motion
timeFrame: PACU discharge
measure: VAS score daily first three days after surgery
timeFrame: daily for three days after surgery
measure: Brief pain inventory (short scale) daily first three days after surgery
timeFrame: daily first three days after surgery
measure: effect of genicular nerve blockade compared to standard peri-incisional local anesthetic
timeFrame: 2 weeks post surgery
measure: Comparing blocks
timeFrame: daily first three days after surgery
measure: Comparing blocks
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Anthony Christiano, MD
role: PRINCIPAL_INVESTIGATOR
References: