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Survey to Participate in HPPL Research Study #00103806

Thank you for your interest in the study.

The Human Pharmacology & Physiology Lab (HPPL) is part of the Department of Anesthesiology at Duke. The lab is physically located within the Duke Early Phase Clinical Research Unit (DEPRU) in Duke Clinics. It is staffed by Attending Anesthesiologists and research support staff.

Local anesthetics are a class of drugs used to provide pain relief (analgesia). The drug works by providing temporary but reversible blockade of sensory nerves responsible for the transmission (carriage) of pain. Local anesthetics are usually injected, either under the skin (termed local infiltration), into the surgical wound (termed wound infiltration) or adjacent to nerves (termed regional anesthesia or nerve blocks). Regional anesthesia (or nerve blocks) can be subdivided into injection around nerves in either the arm or legs (termed peripheral nerve blocks) and neuraxial blocks such as epidural or spinal blocks.

There are many local anesthetics currently approved for regional anesthesia and the physician will select the appropriate local anesthetic based upon several factors, such as duration of analgesia, duration of surgery, etc. Bupivicaine is one of the most commonly used local anesthetics for spinal analgesia, particularly for lower extremity surgery such as hip and knee replacements. One characteristic of spinal bupivicaine is that it provides complete analgesia for approximately 4 - 6 hours, sufficient to complete the surgery, but then wears off with no residual (long lasting) analgesia. In order to prevent the patient from experiencing severe postoperative pain, additional peripheral nerve blocks are placed to provide adequate postoperative analgesia for the next 48 - 72 hours.

Bupivicaine has been formulated in a slow release formulation, called Exparel. This drug formulation is currently FDA approved for wound infiltration and interscalene peripheral nerve block for use in shoulder surgery for postoperative analgesia up to 72 hours. The current study is to determine if Exparel could be used to provide extended analgesia when injected as a spinal analgesic.

Completion of the survey will help determine if you are eligible to participate in this study.

You will be asked some questions that would help the research staff determine if you qualify for the research study. It will take about 5 minutes to complete the survey questions and will provide information about your medical history. Answering these questions is completely voluntary. You are under no obligation to answer them, and if you decide not to answer the questions then this will have no effect on your health care at Duke Health in the future. It does mean, however, that you will not be eligible to participate in this research study. If, at any time during this screening survey you would like to stop and not continue any further, you are free to do so.

If you do qualify for the study and decide to participate, you will be contacted by a member of the study team and asked to attend a Screening Visit at the DEPRU. As soon as you arrive for the Screening Visit, a member of the research team will discuss the study with you. The research team member will provide a detailed explanation of the study and you will have the opportunity to ask questions related to the study. Once you are satisfied, the research team member will ask you to sign the informed consent form (ICF). You can choose to have a paper copy of the signed ICF given to you or request a PDF copy be sent to your email address. Once the ICF is signed the research team will complete the rest of the Screening Visit activities.

To review the full ICF prior to the Enrollment Visit, please click here.

Please note that you should NOT sign the ICF before the Screening Visit.

Please complete the survey below.

Thank you!

First Name

* must provide value

Last Name

* must provide value

Date of Birth

* must provide value

M-D-Y

Preferred Phone Number

* must provide value

Preferred Email Address

* must provide value

Preferred Method of Contact

Phone

Text

Gender

* must provide value

Female

Male

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Ethnic Origin

* must provide value

Alaskan Native or American Indian

Asian

Black or African American

Native Hawaiian or Pacific Islander

White

Other

Race

* must provide value

Hispanic

Non-Hispanic

Height

* must provide value

Weight

* must provide value

Body Mass Index (BMI)

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Are you currently taking any medications?

This includes prescribed medicines, over the counter (OTC) preparations, vitamins and health supplements, birth control and ADHD medications.

* must provide value

Yes

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Please list medications

Have you participated in an investigational drug study (either at Duke or elsewhere) within the last 30 days?

* must provide value

Yes

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Do you smoke or chew tobacco? This includes cigarettes, cigars, & pipes.

* must provide value

Yes

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Have you ever been treated for high blood pressure?

* must provide value

Yes

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Do you have a history of any significant heart or lung condition?

* must provide value

Yes

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Do you have a known allergy or hypersensitivity reaction to local anesthetics, such as lidocaine, bupivacaine or novocaine?

Yes

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One of the exclusion criteria is previous participation in a study sponsored by the pharmaceutical company, Pacira.

Have you previously participated in a research study sponsored by Pacira, either at Duke or another institution?

* must provide value

Yes

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The study requires that you remain confined within the Duke Early Phase Research Unit (DEPRU) for 5 nights (for example, Monday morning to Saturday morning). You will have access to the internet and your phone, but you will not be allowed to leave the unit. If you do, then you will be removed from further participation in the study.

Are you willing to dedicate 5 nights/ 6 days to participate in the study?

* must provide value

Yes

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Would you like to be added to our subject data base to be hear more about future studies?

Yes

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You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.