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
About this trial
This is an interventional treatment trial for Tibial Plateau Fracture
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
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
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