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Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

ConditionTibial Plateau Fractures
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Subjects younger than 18

Polytraumatized Subjects

Subjects with pathologic fractures

Subjects with tibial plateau fractures treated nonoperatively

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacain

    Drug

    5mL 0.25% bupivacain

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Peri-incisional local anesthesiaNo intervention 0 interventions
Group B: Genicular nerve blockadeExperimental treatment 1 intervention

Trial outcomes

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')

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

Secondary outcomes

1

Comparing blocks

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')

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

Block effect on range of motion

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.

Time frame
PACU discharge
3

VAS score 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 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')

Time frame
daily for three days after surgery
4

Brief pain inventory (short scale) 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

Time frame
daily first three days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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