Trial record 4 of 555 for:    Open Studies | "Pain Management"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02085239
First received: March 7, 2014
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pain Management After Breast Biopsy
Drug: Lidocaine Ropivacaine
Drug: Lidocaine alone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Change in pain level from baseline to 1 hour [ Time Frame: 1 hour after procedure ] [ Designated as safety issue: No ]
    Amount of pain that patient is feeling at baseline and 1 hour after the procedure


Secondary Outcome Measures:
  • Change in pain level from 1 hour to 5 hours after procedure [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    Amount of pain that patient is feeling 5 hours after the procedure

  • Change in pain level from 5 to 10 hours after the procedure [ Time Frame: 10 hours after procedure ] [ Designated as safety issue: No ]
    Amount of pain that patient is feeling 10 hours after the procedure

  • Change in pain level from 10 to 24 hours after procedure [ Time Frame: 24 hours after procedure ] [ Designated as safety issue: No ]
    Amount of pain that patient is feeling 24 hours after the procedure

  • Pathology [ Time Frame: up to 72 hours after procedure ] [ Designated as safety issue: No ]
    Description of tissue collected Benign or malignant tumor (if found) Type of tumor


Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine alone
Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection
Drug: Lidocaine alone
Experimental: Lidocaine Ropivacaine

Lidocaine Ropivacaine

  • 8-10 ml of Lidocaine given by subcutaneous injection
  • 8-10 ml of Ropivacaine given by subcutaneous injection
Drug: Lidocaine Ropivacaine
  • 8-10 ml of Lidocaine given by subcutaneous injection
  • 8-10 ml of Ropivacaine given by subcutaneous injection
Other Names:
  • Naropin
  • Ropivacaine HCL

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085239

Contacts
Contact: Tiffany Forde, MS 513-865-5226 tiffany_forde@trihealth.com

Locations
United States, Ohio
Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Tiffany Forde, MS    513-865-5226    tiffany_forde@trihealth.com   
Contact: Brenda Gallo, BS    513-865-1344    brenda_gallo@trihealth.com   
Principal Investigator: Dean Shanley, MD         
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Dean Shanley, MD TriHealth Inc.
  More Information

Publications:
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02085239     History of Changes
Other Study ID Numbers: 13027-13-033
Study First Received: March 7, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
Breast Biopsy
Ultrasound
Lidocaine
Ropivacaine
Breast Lesion

Additional relevant MeSH terms:
Lidocaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014