search
Back to results

Saphenous Nerve Block After Tibial Plateau ORIF

Primary Purpose

Tibial Plateau Fracture, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Saphenous Nerve Block with Ropivacaine Treatment
Saphenous Nerve Block with Saline Control
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Plateau Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Tibial plateau fracture presenting for ORIF
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • Other concomitant life-threatening injuries
  • History of chronic pain prior to tibial plateau ORIF
  • Age <18 years old
  • Pregnancy
  • Any condition impairing patient's ability to consent to participation in study
  • Existing condition contraindicating a nerve block
  • Non-English Speaking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ropivacaine Treatment

    Saline Control

    Arm Description

    After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Ropivacaine through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.

    After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.

    Outcomes

    Primary Outcome Measures

    Pain Scores
    Pain scores on a scale from 0 to 10 will be collected by the research staff for 1 hour following the post-operative block. Pain scores will also be collected by the nurses throughout the patient's stay.
    Opioid requirements
    Opioid medications recorded in opioid morphine equivalents will be recorded by the research staff for the first hour following the post-operative nerve block. Opioid medications will be collected by the nurses throughout the patient's stay.
    Length of Stay
    The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2020
    Last Updated
    July 21, 2023
    Sponsor
    Stanford University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04314570
    Brief Title
    Saphenous Nerve Block After Tibial Plateau ORIF
    Official Title
    Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Fractures of the tibial plateau, while very painful, typically do not receive nerve blocks. This is because of a concern that the numbness from a nerve block would "mask" the typically painful symptoms of compartment syndrome, a condition that can lead to a permanent loss of function of the injured limb. Our study aims to evaluate the effectiveness of saphenous nerve block for pain management after surgical repair of a tibial plateau fracture. Based on cadaver studies and our clinical experience, we suspect that the saphenous nerve contributes to pain sensations of the tibial plateau and will not mask the pain from a compartment syndrome. In summary, while saphenous nerve block represents a safe option after tibial plateau open reduction internal fixation (ORIF), we aim to evaluate its effectiveness in this patient population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tibial Plateau Fracture, Pain, Postoperative

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaine Treatment
    Arm Type
    Experimental
    Arm Description
    After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Ropivacaine through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
    Arm Title
    Saline Control
    Arm Type
    Placebo Comparator
    Arm Description
    After the patient has been consented for a post-operative nerve block, physicians will provide a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
    Intervention Type
    Procedure
    Intervention Name(s)
    Saphenous Nerve Block with Ropivacaine Treatment
    Intervention Description
    Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive ropivacaine through the catheter from the start of the nerve block.
    Intervention Type
    Procedure
    Intervention Name(s)
    Saphenous Nerve Block with Saline Control
    Intervention Description
    Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
    Primary Outcome Measure Information:
    Title
    Pain Scores
    Description
    Pain scores on a scale from 0 to 10 will be collected by the research staff for 1 hour following the post-operative block. Pain scores will also be collected by the nurses throughout the patient's stay.
    Time Frame
    Through hospital stay, an average of 3 days
    Title
    Opioid requirements
    Description
    Opioid medications recorded in opioid morphine equivalents will be recorded by the research staff for the first hour following the post-operative nerve block. Opioid medications will be collected by the nurses throughout the patient's stay.
    Time Frame
    Through hospital stay, an average of 3 days
    Title
    Length of Stay
    Description
    The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.
    Time Frame
    Through hospital stay, an average of 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Tibial plateau fracture presenting for ORIF Age greater than or equal to 18 years Exclusion Criteria: Other concomitant life-threatening injuries History of chronic pain prior to tibial plateau ORIF Age <18 years old Pregnancy Any condition impairing patient's ability to consent to participation in study Existing condition contraindicating a nerve block Non-English Speaking

    12. IPD Sharing Statement

    Learn more about this trial

    Saphenous Nerve Block After Tibial Plateau ORIF

    We'll reach out to this number within 24 hrs