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Opioid Sparing Pain Management Techniques for Gender Affirming Surgery

Phase 3
Recruiting
Led By Maurice M Garcia, M.D., MAS
Research Sponsored by Cedars-Sinai Medical Center
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 any time pain is experienced, starting on the morning of post-operative day 1 to end of study at the final post-operative visit (average of 30 days after surgery)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare different pain treatment options for people undergoing gender-affirming surgery, to see which are more effective in managing post-surgical pain.

Who is the study for?
This trial is for transgender individuals aged 18 or older who are undergoing gender-affirming surgeries with specific doctors. It's not for those with contraindications to study drugs, implanted pain devices, non-English speakers, or anyone unable to sense pain due to neurological deficits.
What is being tested?
The study compares different opioid-sparing pain management techniques after gender-affirming surgery. Techniques include various nerve blocks and local anesthetics like Bupivacaine, aiming to find the most effective method for reducing post-operative pain.
What are the potential side effects?
Potential side effects may include discomfort at injection sites, possible nerve damage leading to numbness or weakness, allergic reactions to anesthetics used in the blocks, and less commonly systemic toxicity from local anesthetics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily, starting on the morning of post-operative day 1 to end of study at the final post-operative visit (average of 30 days after surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and daily, starting on the morning of post-operative day 1 to end of study at the final post-operative visit (average of 30 days after surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the opioid side effect of decreased GI motility and ileus, as indicated by number of post-operative days until commencement of regular passage of flatus
Change in the opioid side effect of nausea, as indicated by number of post-operative days to toleration of liquid diet and regular diet, as well as reported experience of nausea
Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding
+6 more
Secondary study objectives
Time to first day of bowel movement
Time to mobilization

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Group I: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1Active Control7 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the pre-incision, intra-op, mid-surgery, end of surgery, or continuous time points: * Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord) * Local anesthetic (0.25% or 0.5% bupivacaine + 1:200K epinephrine) * Bilateral ultrasound guided pudendal nerve block (20-40 cc of 0.25% bupivacaine + 1:200K epinephrine) * Ultrasound guided Continuous Infraclavicular Brachial Plexus Block * Ultrasound guided Continuous Femoral Nerve Block * Pecs I \& II Block (0.25% bupivacaine: 15-30ml per side for Pecs I-III)
Group II: Surgery-specific general anesthetic + local anesthetic at incision siteActive Control3 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the mid-surgery or end of surgery time points: * Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord) * Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)
Group III: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2Active Control3 Interventions
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the intra-op, post-op, or end of surgery time points: * Bilateral ultrasound-guided Transversus Abdominis Plane Block (40-60cc of 0.25% bupivacaine with 1:200K epinephrine) * Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
513 Previous Clinical Trials
162,749 Total Patients Enrolled
Maurice M Garcia, M.D., MASPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 Clinical Trial Eligibility Overview. Trial Name: NCT04979338 — Phase 3
Gender Dysphoria Research Study Groups: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1, Surgery-specific general anesthetic + local anesthetic at incision site, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2
Gender Dysphoria Clinical Trial 2023: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 Highlights & Side Effects. Trial Name: NCT04979338 — Phase 3
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979338 — Phase 3
~114 spots leftby Aug 2025