RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-11
Study Completion:2025-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04979338

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Transgender persons 18 years and older
  2. * 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)
  1. * Patients who do not meet the inclusion criteria above
  2. * Any contraindications to the study drugs.
  3. * Patients with neurologic deficits that preclude them from sensing pain.
  4. * Patients with implanted pain neuromodulator devices (e.g., neurostimulator)
  5. * Patients who do not speak English

Contacts and Locations

Study Contact

Jenna Stelmar, BS
CONTACT
805-813-7882
jenna.stelmar@cshs.org

Principal Investigator

Maurice M Garcia, M.D., MAS
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center - North and South Towers
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Maurice M Garcia, M.D., MAS, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-11
Study Completion Date2025-08-30

Study Record Updates

Study Start Date2021-11-11
Study Completion Date2025-08-30

Terms related to this study

Keywords Provided by Researchers

  • Gender Dysphoria
  • Gender-Affirming Surgery
  • Peri-Operative Pain
  • Pain Management
  • Surgery Pain
  • Sex Reassignment Surgery
  • Gender Reassignment Surgery
  • Vaginoplasty
  • Phalloplasty
  • Quality Improvement
  • Opioid Use

Additional Relevant MeSH Terms

  • Gender Dysphoria