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

Pain Management After Breast Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02085239
• Other study ID #: 13027-13-033
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2017
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Management After Breast Biopsy

Intervention

Drug:
• Lidocaine Ropivacaine
8-10 ml of Lidocaine given by subcutaneous injection 8-10 ml of Ropivacaine given by subcutaneous injection
• Lidocaine alone

Locations

Country	Name	City	State
United States	Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Applied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012

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. — View Citation

Reynolds HE, Jackson VP, Musick BS. Preoperative needle localization in the breast: utility of local anesthesia. Radiology. 1993 May;187(2):503-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Pathology	Description of tissue collected Benign or malignant tumor (if found) Type of tumor	up to 72 hours after procedure