Pain Management After Breast BiopsyPhase 4NCT02085239
Comparison of Long vs. Short Acting Anesthesia for Improving Pain Management After Breast Biopsy
A Phase 4 study testing Lidocaine Ropivacaine and Lidocaine alone in people with Pain Management After Breast Biopsy, run by TriHealth Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain Management After Breast Biopsy
- What is being tested?
- Lidocaine Ropivacaine and Lidocaine alone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with breast lesions recommended for biopsy by physician
Who cannot join
- Patients with breast lesions not recommended for biopsy
- Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital
Cincinnati, Ohio, 45242
About this study
Official title: Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy
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.
Read the 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.
- Conditions
- Pain Management After Breast Biopsy
- Being tested
- Lidocaine Ropivacaine, Lidocaine alone
- Keywords
- Breast Biopsy, Ultrasound, Lidocaine, Ropivacaine, Breast Lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine RopivacaineDrug
Also called Naropin, Ropivacaine HCL
- 8-10 ml of Lidocaine given by subcutaneous injection
- 8-10 ml of Ropivacaine given by subcutaneous injection
Lidocaine aloneDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine alone | Active comparator | Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection Receives: Drug: Lidocaine alone |
| Lidocaine Ropivacaine | Experimental | Lidocaine Ropivacaine
* 8-10 ml of Lidocaine given by subcutaneous injection
* 8-10 ml of Ropivacaine given by subcutaneous injection Receives: Drug: Lidocaine Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level from baseline to 1 hour
Amount of pain that patient is feeling at baseline and 1 hour after the procedure
Measured: 1 hour after procedure
Secondary outcomes (4)
Change in pain level from 1 hour to 5 hours after procedure
Amount of pain that patient is feeling 5 hours after the procedure
Measured: 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
Measured: 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
Measured: 24 hours after procedure
Pathology
Description of tissue collected Benign or malignant tumor (if found) Type of tumor
Measured: up to 72 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Study never got started; can't delete results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain Management After Breast BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Shanley, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085239
- Sponsor's protocol ID
- 13027-13-033
- Status last verified
- Apr 2017
- First submitted
- 7 Mar 2014
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Applied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012
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.
PubMed 8475298Novy 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.
PubMed 11394538
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Long Acting vs. Short Acting Anesthetic Agents as a Tool for Improving Pain Management Post Ultrasound Guided Breast Biopsy
- ClinicalTrials.gov ID
- NCT02085239
- Acronym / sponsor ID
- 13027-13-033
- Conditions
- Pain Management After Breast Biopsy
- Keywords
- Breast Biopsy, Ultrasound, Lidocaine, Ropivacaine, Breast Lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never got started; can't delete results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine alone | Active comparator | Drug: Lidocaine aloneLidocaine: 8-10 ml of Lidocaine by subcutaneous injection |
| Lidocaine Ropivacaine | Experimental | Drug: Lidocaine RopivacaineLidocaine Ropivacaine * 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with breast lesions recommended for biopsy by physician
Key exclusion criteria (2 listed)
- Patients with breast lesions not recommended for biopsy
- Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine RopivacaineAlso: Naropin, Ropivacaine HCL* 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection | Drug | Lidocaine Ropivacaine |
| Lidocaine alone | Drug | Lidocaine alone |
Primary outcome
Change in pain level from baseline to 1 hour
Time frame: 1 hour after procedure
Amount of pain that patient is feeling at baseline and 1 hour after the procedure
4 secondary outcomes
Change in pain level from 1 hour to 5 hours after procedure
Time frame: 5 hours
Change in pain level from 5 to 10 hours after the procedure
Time frame: 10 hours after procedure
Change in pain level from 10 to 24 hours after procedure
Time frame: 24 hours after procedure
Pathology
Time frame: up to 72 hours after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- BackgroundApplied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012
- Background: PubMed 8475298Reynolds 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.
- Background: PubMed 11394538Novy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Shanley, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Ropivacaine and Lidocaine alone in people with Pain Management After Breast Biopsy, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level from baseline to 1 hour (time frame: 1 hour after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085239, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.