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Group 3 Arm A for Satisfaction
Phase 4
Waitlist Available
Led By Venkat K Rao, MD, MBA
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after surgery
Awards & highlights
Study Summary
This trial is looking at different ways to manage pain after breast surgery, specifically comparing a paravertebral block (PVB) to standard pain management techniques, as well as comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care.
Eligible Conditions
- Satisfaction
- Postoperative Vomiting
- Opioid Use Disorder
- Acute Pain
- Nausea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Analgesic requirements (pain medication quantity)
Anti-emetic requirements (anti-nausea medication quantity)
Numerical Pain Scores, rated by patient on 0-10 scale
+4 moreTrial Design
8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Group 4 Arm AExperimental Treatment3 Interventions
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
Group II: Group 3 Arm AExperimental Treatment2 Interventions
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
Group III: Group 2 Arm AExperimental Treatment2 Interventions
Breast augmentation with Paravertebral block using local anesthetic.
Group IV: Group 1 Arm AExperimental Treatment2 Interventions
Breast reduction with Paravertebral block using local anesthetic.
Group V: Group 4 Arm BActive Control1 Intervention
Breast augmentation, standard perioperative management.
Group VI: Group 3 Arm BActive Control1 Intervention
Breast reduction, standard perioperative management.
Group VII: Group 1 Arm BPlacebo Group2 Interventions
Breast reduction with Sham paravertebral block using saline.
Group VIII: Group 2 Arm BPlacebo Group2 Interventions
Breast augmentation with Sham paravertebral block using saline.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,291 Total Patients Enrolled
Venkat K Rao, MD, MBAPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who regularly take opioid pain medications before surgery.Women who have had problems with opioid drugs in the past.Women who have had an infection at the area where a paravertebral block was performed in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Group 4 Arm B
- Group 2: Group 3 Arm B
- Group 3: Group 1 Arm B
- Group 4: Group 2 Arm B
- Group 5: Group 3 Arm A
- Group 6: Group 4 Arm A
- Group 7: Group 2 Arm A
- Group 8: Group 1 Arm A
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enlisted for this research project?
"Affirmative. Information hosted on clinicaltrials.gov confirms that this experiment is actively seeking participants, which began posting for recruitment on September 1st 2017 and most recently was edited October 11th 2022. The study demands 296 patients recruited from a single medical facility."
Answered by AI
Are there still opportunities to enroll in this clinical research?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is recruiting participants, with the initial post on September 1st 2017 and a recent update on October 11th 2022. The study needs 296 patients from one location to participate."
Answered by AI
Has Group 3 Arm A earned FDA clearance?
"With Group 3 Arm A being a Phase 4 trial, and thus having approval from regulatory bodies, it receives the highest safety rating of 3."
Answered by AI
Who else is applying?
What state do they live in?
Arizona
What site did they apply to?
University of Wisconsin Madison
What portion of applicants met pre-screening criteria?
Met criteria
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