Development of Effective Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    640
  • sponsor
    Cedars-Sinai Medical Center
Updated on 6 August 2021

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.

Details
Condition Gender Dysphoria
Treatment Bupivacaine, Local anesthetic, Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block, Bilateral ultrasound guided Transversus Abdominis Plane Block, Bilateral spermatic cord block, Pecs I & II Block
Clinical Study IdentifierNCT04979338
SponsorCedars-Sinai Medical Center
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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