Comparison of Long vs. Short Acting Anesthesia for Improving Pain Management After Breast Biopsy

Study Overview
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Brief Summary
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This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.

Detailed Description
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The purpose of this study is to evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast. One group of patients will receive lidocaine alone for local anesthesia. A second group of patients will similarly receive lidocaine prior to tissue sampling, followed by infiltration of the biopsy area with ropivacaine. Our hypothesis is that patients who receive a long acting anesthetic (ropivacaine) along with the popular short acting anesthetic (lidocaine), will be pain free after the breast biopsy procedure for a longer period of time than the patients who only receive lidocaine (the short acting anesthetic). This will lessen the emotional and physical trauma associated with the procedure and give patients a better experience thereby improving patient care.

Official Title
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Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy

Conditions
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Pain Management After Breast Biopsy

Intervention / Treatment
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* Drug: Lidocaine Ropivacaine
* Drug: Lidocaine alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with breast lesions recommended for biopsy by physician Exclusion Criteria: Patients with breast lesions not recommended for biopsy Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine alone<br>Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection | Drug: Lidocaine alone<br> <br> |
| Experimental: Lidocaine Ropivacaine<br>Lidocaine Ropivacaine 8-10 ml of Lidocaine given by subcutaneous injection 8-10 ml of Ropivacaine given by subcutaneous injection | Drug: Lidocaine Ropivacaine<br>* 8-10 ml of Lidocaine given by subcutaneous injection 8-10 ml of Ropivacaine given by subcutaneous injection<br>* Other names: Ropivacaine HCL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level from baseline to 1 hour | Amount of pain that patient is feeling at baseline and 1 hour after the procedure | 1 hour after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain level from 1 hour to 5 hours after procedure | Amount of pain that patient is feeling 5 hours after the procedure | 5 hours | 
| Change in pain level from 5 to 10 hours after the procedure | Amount of pain that patient is feeling 10 hours after the procedure | 10 hours after procedure | 
| Change in pain level from 10 to 24 hours after procedure | Amount of pain that patient is feeling 24 hours after the procedure | 24 hours after procedure | 
| Pathology | Description of tissue collected Benign or malignant tumor (if found) Type of tumor | up to 72 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Biopsy, Ultrasound, Lidocaine, Ropivacaine, Breast Lesion