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

Phase 4

Withdrawn

• Conditions: Pain Management After Breast Biopsy
• Interventions: Drug: Lidocaine Ropivacaine; Drug: Lidocaine alone

• Registration Number: NCT02085239
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-04
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Ropivacaine	Lidocaine Ropivacaine	Lidocaine Ropivacaine * 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection
Lidocaine alone	Lidocaine alone	Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Change in pain level from baseline to 1 hour	1 hour after procedure	Amount of pain that patient is feeling at baseline and 1 hour after the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States