Saphenous Nerve Block After Tibial Plateau ORIF

Pain, Postoperative Clinical Trial

Official title:

Saphenous Nerve Block for Post-Op Pain Control After Tibial Plateau ORIF

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04314570
• Other study ID #: 31480
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Tibial Plateau Fracture

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