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

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979338
• Other study ID #: STUDY00000879
• Status: Recruiting
• Phase: Phase 3
• Start date: November 11, 2021
• Est. completion date: August 30, 2025

Study information

• Verified date: June 2024
• Source: Cedars-Sinai Medical Center
• Contact: Jenna Stelmar, BS
• Phone: 805-813-7882
• Email: jenna.stelmar[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gender Dysphoria

Intervention

Other:
• Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op [administered by anesthesiologist]
• Ultrasound guided Continuous Femoral Nerve Block
20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op [administered by anesthesiologist]
• Ultrasound guided Pudendal Nerve Block
20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision]

Drug:
• Bupivacaine
0.25% or 0.5% with or without 1:200K epinephrine

Other:
• Bilateral ultrasound guided Transversus Abdominis Plane Block
40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery]
• Bilateral spermatic cord block
10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]
• Pecs I & II Block
0.25% bupivacaine: 15-30mL per side for Pecs I-III
• Local anesthetic
0.25% or 0.5% bupivacaine into the appropriate surgical site

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center - North and South Towers	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps	Anterior and posterior illustrations of the body, with pre-defined areas involved in surgery that may be circled, will be used to define pain location. Pain scores for each circled area will be measured on a Likert-scale between 0-10, with 0 indicating no pain and 10 indicating the worst pain experienced in respondent's life.	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)
Primary	Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient	Inpatient opioid consumption will be obtained from hospital records. Outpatient opioid consumption will be determined from completed medication logs. Opioid consumption will be measured per 24 hours, by hospital location (e.g., PACU versus Ward), and by post-operative day.	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)
Primary	Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding	Recorded time to spontaneous voiding will be collected from hospital records.	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Primary	Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire	A Urinary Bother Symptom Score Questionnaire, obtained from the American Urological Association, will assess the frequency of different urinary problems, such as incomplete emptying, intermittency, and urgency. Each urinary problem will be measured on a scale from 0 to 5, with 0 indicating "none/not at all" and 5 indicating "almost always."	Pre-operative visit, Discharge (average of 7 days after surgery), and End of Study/final post-operative visit (average of 30 days after surgery)
Primary	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	Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Primary	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	Recorded number of post-operative days and experience of nausea will be obtained from hospital records.	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Primary	Post-operative length of inpatient stay	Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Primary	Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory	Questions 1-10 will assess global well-being and physical comfort, such as ability to return to work or usual home activities, feeling rested, ability to enjoy food, and general feelings of well-being. These questions will be rated on a scale of 0 to 10, with 0 indicating none of the time (poor) and 10 indicating all of the time (excellent).; Questions 11-15 will assess pain and physical comfort, such as presence of moderate/severe pain, nausea or vomiting, worried or anxious feelings, and sad or depressed feelings. These questions will be rated on a scale of 0 to 10, with 0 indicating all of the time (poor) and 10 indicating none of the time (excellent).	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)
Primary	Frequency of treatment complications	Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.	End of study (average of 30 days after surgery)
Secondary	Time to mobilization	The recorded number of days to mobilization will be obtained from hospital records.	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Secondary	Time to first day of bowel movement	The recorded number of days to first bowel movement will be obtained from hospital records.	Post-operative Day 1 to Discharge (average of 7 days after surgery)
Secondary	Number of participants with any hospital readmission within 30 days of discharge		30 days after Day of Discharge (average of 7 days after surgery)