Clinical trial NCT04979338: Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Official title: Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gender Dysphoria
Keywords: Gender Dysphoria
Gender-Affirming Surgery
Peri-Operative Pain
Pain Management
Surgery Pain
Sex Reassignment Surgery
Gender Reassignment Surgery
Vaginoplasty
Phalloplasty
Quality Improvement
Opioid Use
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps
timeFrame: 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)
measure: Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient
timeFrame: Per 24 hours, starting on post-operative Day 1 to End of Study at the final post-operative visit (average of 30 days after surgery)
measure: Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire
timeFrame: Pre-operative visit, Discharge (average of 7 days after surgery), and End of Study/final post-operative visit (average of 30 days after surgery)
measure: 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
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: 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
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: Post-operative length of inpatient stay
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory
timeFrame: 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)
measure: Frequency of treatment complications
timeFrame: End of study (average of 30 days after surgery)
Secondary outcomes:
measure: Time to mobilization
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: Time to first day of bowel movement
timeFrame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
measure: Number of participants with any hospital readmission within 30 days of discharge
timeFrame: 30 days after Day of Discharge (average of 7 days after surgery)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center - North and South Towers
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Maurice M Garcia, M.D., MAS
role: PRINCIPAL_INVESTIGATOR
References: