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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Number of participants with any hospital readmission within 30 days of discharge
Time to first day of bowel movement
Time to mobilization

Trial Design

3Treatment groups
Active Control
Group I: 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 II: 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 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
502 Previous Clinical Trials
165,053 Total Patients Enrolled
Maurice M Garcia, M.D., MASPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other reports of using a general anesthetic in combination with a local anesthetic at the surgical site?

"There are 124 clinical trials currently underway for Surgery-specific general anesthetic + local anesthetic at incision site. Of those, 21 are in Phase 3. Many of the trials for this treatment are based in Philadelphia, Pennsylvania, but there are a total of 169 locations running trials for this treatment."

Answered by AI

Can patients still sign up for this experiment?

"The information available on clinicaltrials.gov supports that this trial is still looking for recruits. The study was posted on November 11th, 2021 and the most recent update was March 11th, 2022. So far, 640 people have signed up at the single site location."

Answered by AI

For what types of procedures is Surgery-specific general anesthetic + local anesthetic at incision site most effective?

"Surgery-specific general anesthetic + local anesthetic at incision site is the standard of care for permphigus. This treatment method is also used to manage acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

How many people are choosing to participate in this clinical investigation?

"The trial is currently ongoing and was last updated 3/11/2022. It was initially posted 11/11/2021. The study is looking for 640 patients from 1 site."

Answered by AI

Does the FDA sanction the use of general anesthetic during surgery in combination with local anesthetic at the site of incision?

"There is some efficacy data and multiple rounds of safety data for Surgery-specific general anesthetic + local anesthetic at incision site, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Cedars-Sinai Medical Center - North and South Towers
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Maurice M. Garcia 2021. "Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04979338.
All > Transgender
~58 spots leftby Aug 2024
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