Single Shot Versus OnQ Pump in Extremity Fractures

Completed · Phase 4

Conditions studied: Pain, Fracture

In brief

Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.

Key facts

Study ID

NCT02280291

Run by

NYU Langone Health

People needed

100

Starts

2013-08-01

Expected to finish

2018-12-13

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients at least 18 years old.
• Male or Female
• All racial and ethnic groups
• Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand
• Patients who opt for surgical treatment of their fractures.
• Patients who consent to be randomized.
• Patients who are willing to follow-up for a minimum of 52 weeks.

You may not qualify if…

• Patients younger than 18 years old.
• Patients who are on chronic opioids
• Patients who abuse opioids
• Patients who are unwilling to follow-up for a minimum of 52 weeks.
• Neurologic condition that could interfere with pain sensation

Where it is running

• Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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