NCT04979338PHASE3Recruiting
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Cedars-Sinai Medical Center
Start Date
11/11/2021
Completion Date
9/30/2026
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
Age Range: 18 years to No maximum
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
Interventions
OTHER
Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
OTHER
Ultrasound guided Continuous Femoral Nerve Block
OTHER
Ultrasound guided Pudendal Nerve Block
DRUG
Bupivacaine
OTHER
Bilateral ultrasound guided Transversus Abdominis Plane Block
OTHER
Bilateral spermatic cord block
OTHER
Pecs I & II Block
OTHER
Local anesthetic
Conditions
Gender Dysphoria
Locations
Cedars-Sinai Medical Center - North and South Towers
Los Angeles, California 90048
United States