Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

NCT06639503 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB23-0930
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Plateau Fractures

Keywords

peri-incisional local anesthesia; genicular nerve block; Tibial Plateau Fractures; open reduction internal fixation

Outcome Measures

Primary Outcomes (1)

• 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')

  one hour, two hours, and discharge from PACU

Secondary Outcomes (7)

• Comparing blocks

  one hour after surgery, 2 hours after surgery, and discharge from PACU

• Block effect on range of motion

  PACU discharge

• VAS score daily first three days after surgery

  daily for three days after surgery

• Brief pain inventory (short scale) daily first three days after surgery

  daily first three days after surgery

• effect of genicular nerve blockade compared to standard peri-incisional local anesthetic

  2 weeks post surgery

Study Arms (2)

Peri-incisional local anesthesia

NO INTERVENTION

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

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

Interventions

Bupivacain DRUG

5mL 0.25% bupivacain

Genicular nerve blockade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Anthony Christiano, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Christiano, MD

CONTACT

773-834-3531; anthony.christiano@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The envelope will be opened in the operating room prior to beginning the procedure. This ensures subjects are blinded to their treatment modality.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 14, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)