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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04314570
Other study ID # 31480
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2025
Est. completion date May 2026

Study information

Verified date May 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Saphenous Nerve Block with Ropivacaine Treatment
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.
Saphenous Nerve Block with Saline Control
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through hospital stay, an average of 3 days
Primary 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. Through hospital stay, an average of 3 days
Primary Length of Stay The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge. Through hospital stay, an average of 3 days
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