NCT04979338 Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
| NCT ID | NCT04979338 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Gender Dysphoria |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2021-11-11 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 640 participants in total. It began in 2021-11-11 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Transgender persons 18 years and older * Undergoing gender affirming surgeries performed by either Dr. Maurice Garcia (orchiectomy only, vaginoplasty with or without canal \& orchiectomy, colon-vaginoplasty, \& peritoneal vaginoplasty; Stage I phalloplasty, or stage II phalloplasty); Dr. Edward Ray (feminizing chest surgery, masculinizing chest surgery, stage I phalloplasty); Dr. Amit Gupta (orchiectomy and peritoneal vaginoplasty only); or Dr. Yosef Nasseri (colon vaginoplasty surgery) Exclusion Criteria: * Patients who do not meet the inclusion criteria above * Any contraindications to the study drugs. * Patients with neurologic deficits that preclude them from sensing pain. * Patients with implanted pain neuromodulator devices (e.g., neurostimulator) * Patients who do not speak English
Contact & Investigator
Maurice M Garcia, M.D., MAS
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT04979338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gender Dysphoria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04979338 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 640 participants.
Is NCT04979338 currently recruiting?
Yes, NCT04979338 is actively recruiting participants. Contact the research team at jenna.stelmar@cshs.org for enrollment information.
Where is the NCT04979338 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04979338 clinical trial?
NCT04979338 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Maurice M Garcia, M.D., MAS at Cedars-Sinai Medical Center. The trial plans to enroll 640 participants.