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NCT04979338 · ClinicalTrials.gov registry record · Phase 3
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
A Phase 3 study of Gender Dysphoria, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 640
- Enrollment target
- 1
- Study location
NCT04979338: Recruiting Phase 3 study of Gender Dysphoria, sponsored by Cedars-Sinai Medical Center.
NCT04979338 is a Phase 3 study of Gender Dysphoria that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 640 participants, above the 99-participant average among 8 other Gender Dysphoria trials with a reported enrollment target (546% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04979338, a Phase 3 study of Gender Dysphoria, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 640 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.
Primary Outcome
Anterior and posterior illustrations of the body, with pre-defined areas involved in surgery that may be circled, will be used to define pain location. Pain scores for each circled area will be measured on a Likert-scale between 0-10, with 0 indicating no pain and 10 indicating the worst pain experienced in respondent's life.
Conditions Studied
Interventions
- DRUG Bupivacaine
- OTHER Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
- OTHER Ultrasound guided Continuous Femoral Nerve Block
- OTHER Ultrasound guided Pudendal Nerve Block
- OTHER Bilateral ultrasound guided Transversus Abdominis Plane Block
Study Locations (1)
California
- Cedars-Sinai Medical Center - North and South Towers - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 640 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 3 |
What NCT04979338 shows while recruiting
NCT04979338 is an interventional study that assigns participants to a tested intervention. The registered 640 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 8 other Gender Dysphoria trials with a reported enrollment target (546% higher).
The record links to 1 condition, with Gender Dysphoria appearing as the primary indexed condition, and to 5 interventions - of which Bupivacaine is the first listed.
NCT04979338 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04979338 about?
NCT04979338 is a clinical study titled "Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries". This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pai...
What is the current status of trial NCT04979338?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 640 participants. The study started on 2021-11-11. Estimated completion is 2026-09-30.
What conditions does trial NCT04979338 study?
This clinical trial studies the following conditions: Gender Dysphoria.
What interventions are being tested in trial NCT04979338?
The interventions under investigation include: Bupivacaine (DRUG), Ultrasound guided Continuous Infraclavicular Brachial Plexus Block (OTHER), Ultrasound guided Continuous Femoral Nerve Block (OTHER), Ultrasound guided Pudendal Nerve Block (OTHER), Bilateral ultrasound guided Transversus Abdominis Plane Block (OTHER).
Who is sponsoring clinical trial NCT04979338?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04979338 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04979338's enrollment target sits among peer trials
640 1st of 8 higher than 8 of 8 other Gender Dysphoria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gender Dysphoria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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