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Ropivacaine for Gender Dysphoria
Phase 4
Waitlist Available
Led By Esther Kim, MD
Research Sponsored by University of California, San Francisco
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 post operative
Awards & highlights
Study Summary
This study is evaluating whether a nerve block can reduce pain and opioid consumption in patients undergoing gender-affirmation breast surgery.
Eligible Conditions
- Gender Dysphoria
- Opioid Use Disorder
- Postoperative Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of Post Operative Pain Scores
Secondary outcome measures
Comparison of Intra Operative Narcotic Requirements
Comparison of Post Operative Narcotic Requirements
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RopivacaineExperimental Treatment1 Intervention
Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).
Group II: SalinePlacebo Group1 Intervention
Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine 0.2% Injectable Solution
2021
Completed Phase 4
~530
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,421 Total Patients Enrolled
1 Trials studying Gender Dysphoria
3 Patients Enrolled for Gender Dysphoria
Esther Kim, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
1,150 Total Patients Enrolled
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