Saphenous Nerve Block After Tibial Plateau ORIF

Not Applicable

Not yet recruiting

• Conditions: Tibial Plateau Fracture; Pain, Postoperative
• Interventions: Procedure: Saphenous Nerve Block with Saline Control; Procedure: Saphenous Nerve Block with Ropivacaine Treatment

• Registration Number: NCT04314570
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Control	Saphenous Nerve Block with Saline Control	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.
Ropivacaine Treatment	Saphenous Nerve Block with Ropivacaine Treatment	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.

Primary Outcome Measures

Name	Time	Method
Pain Scores	Through hospital stay, an average of 3 days	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	Through hospital stay, an average of 3 days	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	Through hospital stay, an average of 3 days	The patient's length of stay in the hospital will be collected by the research staff following the patient's discharge.