Saphenous Nerve Block After Tibial Plateau ORIF

NCT04314570 | Not Yet Recruiting

• 1 other identifier: 31480
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Ropivacaine Treatment

EXPERIMENTAL

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.

Procedure: Saphenous Nerve Block with Ropivacaine Treatment

Saline Control

PLACEBO COMPARATOR

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.

Procedure: Saphenous Nerve Block with Saline Control

Interventions

Saphenous Nerve Block with Ropivacaine Treatment 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.

Ropivacaine Treatment

Saphenous Nerve Block with Saline Control 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.

Saline Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Tibial Plateau Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05