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NCT Number: NCT06639503

Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Anthony Christiano, MD

CONTACT

[email protected]

Anthony Christiano, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

Drug

5mL 0.25% bupivacain

Primary outcomes

  1. Pain Ratings from Visual Analog Scale (VAS)

    Time frame: one hour, two hours, and discharge from PACU

    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')

Secondary outcomes

  1. Comparing blocks

    Time frame: one hour after surgery, 2 hours after surgery, and discharge from PACU

    To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using they Visual analog (VAS) scale. 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')

  2. Block effect on range of motion

    Time frame: PACU discharge

    To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on postoperative function as assessed by postoperative knee range of motion at time of Post Anesthesia Care Unit (PACU) discharge.

  3. VAS score daily first three days after surgery

    Time frame: daily for three days after surgery

    To determine the effect of genicular nerve block compared to standard peri-incisional local anesthetic on pain control for the first three days after surgery as measured by the visual analog scale. 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')

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

    Time frame: daily first three days after surgery

    To determine the effect of genicular nerve block compared to standard peri-incisional local anesthetic on pain control for the first three days after surgery as measured by the Brief pain inventory (short scale). the brief pain inventory (Short form) uses a 0 to 10 numeric rating scales for item rating.

    1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain

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

    Time frame: 2 weeks post surgery

    To determine the effect of genicular nerve blockade compared to standard peri-incisional local anesthetic on opiate use as determined by the number of prescription opiate pain pills remaining at 2 weeks post surgery.

  6. Comparing blocks

    Time frame: daily first three days after surgery

    To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using the Brief pain inventory (short form). the brief pain inventory (Short form) uses a 0 to 10 numeric rating scales for item rating.

    1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain

  7. Comparing blocks

    Time frame: 2 weeks after surgery

    To assess the effect of genicular nerve block compared to standard peri-incisional local anesthetic on analgesic consumption in the Post Anesthesia Care Unit (PACU) using opiate pill counts.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Christiano, MD

CONTACT

[email protected]

773-834-3531

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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