Clinical trial NCT02085239: Comparison of Long vs. Short Acting Anesthesia for Improving Pain Management After Breast Biopsy
Official title: Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain Management After Breast Biopsy
Keywords: Breast Biopsy
Ultrasound
Lidocaine
Ropivacaine
Breast Lesion
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain level from baseline to 1 hour
timeFrame: 1 hour after procedure
Secondary outcomes:
measure: Change in pain level from 1 hour to 5 hours after procedure
timeFrame: 5 hours
measure: Change in pain level from 5 to 10 hours after the procedure
timeFrame: 10 hours after procedure
measure: Change in pain level from 10 to 24 hours after procedure
timeFrame: 24 hours after procedure
measure: Pathology
timeFrame: up to 72 hours after procedure
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Dean Shanley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Applied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012
citation: Reynolds HE, Jackson VP, Musick BS. Preoperative needle localization in the breast: utility of local anesthesia. Radiology. 1993 May;187(2):503-5. doi: 10.1148/radiology.187.2.8475298.
citation: Novy DM, Price M, Huynh PT, Schuetz A. Percutaneous core biopsy of the breast: correlates of anxiety. Acad Radiol. 2001 Jun;8(6):467-72. doi: 10.1016/S1076-6332(03)80617-7.