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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 weeks3 visits

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)

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

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)

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