Saphenous Nerve Block After Tibial Plateau ORIF

NCT ID: NCT04314570

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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.

Conditions

Tibial Plateau Fracture; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Saphenous Nerve Block with Ropivacaine Treatment

Intervention Type: PROCEDURE

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.

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.

Group Type: PLACEBO_COMPARATOR

Saphenous Nerve Block with Saline Control

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jean-Louis Horn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

31480

Identifier Type: -

Identifier Source: org_study_id