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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria
• Intervention / Treatment: 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 spermatic cord block; Other: Pecs I & II Block; Other: Local anesthetic; Other: Bilateral ultrasound guided Transversus Abdominis Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jenna Stelmar, BS; Phone Number: 805-813-7882; Email: jenna.stelmar@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center - North and South Towers
      • Contact: Maurice M Garcia, M.D., MAS; Phone Number: 310-423-4256; Email: maurice.garcia@csmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1; Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the pre-incision, intra-op, mid-surgery, end of surgery, or continuous time points: Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord); Local anesthetic (0.25% or 0.5% bupivacaine + 1:200K epinephrine); Bilateral ultrasound guided pudendal nerve block (20-40 cc of 0.25% bupivacaine + 1:200K epinephrine); Ultrasound guided Continuous Infraclavicular Brachial Plexus Block; Ultrasound guided Continuous Femoral Nerve Block; Pecs I & II Block (0.25% bupivacaine: 15-30ml per side for Pecs I-III)	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]; Other: 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]; Other: 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 Names: Marcaine; Other: Bilateral spermatic cord block; 10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]; Other: Pecs I & II Block; 0.25% bupivacaine: 15-30mL per side for Pecs I-III; Other: Local anesthetic; 0.25% or 0.5% bupivacaine into the appropriate surgical site
Active Comparator: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2; Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the intra-op, post-op, or end of surgery time points: Bilateral ultrasound-guided Transversus Abdominis Plane Block (40-60cc of 0.25% bupivacaine with 1:200K epinephrine); Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)	Drug: Bupivacaine; 0.25% or 0.5% with or without 1:200K epinephrine; Other Names: Marcaine; Other: Local anesthetic; 0.25% or 0.5% bupivacaine into the appropriate surgical site; 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]
Active Comparator: Surgery-specific general anesthetic + local anesthetic at incision site; Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the mid-surgery or end of surgery time points: Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord); Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)	Drug: Bupivacaine; 0.25% or 0.5% with or without 1:200K epinephrine; Other Names: Marcaine; Other: Bilateral spermatic cord block; 10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]; Other: Local anesthetic; 0.25% or 0.5% bupivacaine into the appropriate surgical site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Number of participants with any hospital readmission within 30 days of discharge		30 days after Day of Discharge (average of 7 days after surgery)

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Maurice M Garcia, M.D., MAS, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Opioid Use; Quality Improvement; Pain Management; Vaginoplasty; Gender Dysphoria; Gender-Affirming Surgery; Peri-Operative Pain; Surgery Pain; Sex Reassignment Surgery; Gender Reassignment Surgery; Phalloplasty
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Sexual Dysfunctions, Psychological; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gender Dysphoria; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anilides; Amides; Aniline Compounds; Amines; Digestive System and Oral Physiological Phenomena; Central Nervous System Agents; Dentistry; Dental Physiological Phenomena; Bupivacaine; Anesthetics, Local; Dental Occlusion
• Other Study ID Numbers: STUDY00000879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes