Pain, Postoperative Clinical Trial
Official title:
Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF
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 |
Verified date | May 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
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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