Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

The University of Chicago

Status and phase: Enrolling; Phase 1

Conditions: Tibial Plateau Fractures

Treatments: Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT06639503

IRB23-0930

Details and patient eligibility

About

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.

Full 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).

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Peri-incisional local anesthesia

No Intervention group

Description:

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 group

Description:

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

Treatment:

Drug: Bupivacain