Saphenous Nerve Block After Tibial Plateau ORIF

Stanford University

Status: Not yet enrolling

Conditions: Tibial Plateau Fracture; Pain, Postoperative

Treatments: Procedure: Saphenous Nerve Block with Saline Control; Procedure: Saphenous Nerve Block with Ropivacaine Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04314570

31480

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Ropivacaine Treatment

Experimental group

Description:

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.

Treatment:

Procedure: Saphenous Nerve Block with Ropivacaine Treatment

Saline Control

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Saphenous Nerve Block with Saline Control