Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

NCT ID: NCT06639503

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-06-14

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).

Conditions

Tibial Plateau Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Peri-incisional local anesthesia

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Genicular nerve blockade

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

Group Type: EXPERIMENTAL

Bupivacain

Intervention Type: DRUG

5mL 0.25% bupivacain

Interventions

Bupivacain

5mL 0.25% bupivacain

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Christiano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anthony Christiano, MD

Role: CONTACT

anthony.christiano@bsd.uchicago.edu

773-834-3531

Facility Contacts

Anthony Christiano, MD

Role: primary

anthony.christiano@bsd.uchicago.edu

Other Identifiers

IRB23-0930

Identifier Type: -

Identifier Source: org_study_id