Gender DysphoriaPhase 3NCT04979338
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
A Phase 3 study testing Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block and Ultrasound guided Pudendal Nerve Block in people with Gender Dysphoria, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block and Ultrasound guided Pudendal Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 30 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center - North and South Towers
Los Angeles, California, 90048
Maurice M Garcia, M.D., MAS, 310-423-4256, maurice.garcia@csmc.edu
About this study
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.
- Conditions
- Gender Dysphoria
- Being tested
- Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block, Bupivacaine, Bilateral ultrasound guided Transversus Abdominis Plane Block
- 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
- Medical subject headings
- Gender Dysphoria, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Continuous Infraclavicular Brachial Plexus BlockOther
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 BlockOther
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 BlockOther
20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision]
BupivacaineDrug
Also called Marcaine
0.25% or 0.5% with or without 1:200K epinephrine
Bilateral ultrasound guided Transversus Abdominis Plane BlockOther
40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery]
Bilateral spermatic cord blockOther
10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]
Pecs I & II BlockOther
0.25% bupivacaine: 15-30mL per side for Pecs I-III
Local anestheticOther
0.25% or 0.5% bupivacaine into the appropriate surgical site
| Study group | Role | What they receive |
|---|---|---|
| Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 | Active comparator | 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) Receives: 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 |
| Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 | Active comparator | 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) Receives: Drug: Bupivacaine; Other: Bilateral ultrasound guided Transversus Abdominis Plane Block; Other: Local anesthetic |
| Surgery-specific general anesthetic + local anesthetic at incision site | Active comparator | 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) Receives: Drug: Bupivacaine; Other: Bilateral spermatic cord block; Other: Local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: End of study (average of 30 days after surgery)
Secondary outcomes (3)
Time to mobilization
The recorded number of days to mobilization will be obtained from hospital records.
Measured: 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.
Measured: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Number of participants with any hospital readmission within 30 days of discharge
Measured: 30 days after Day of Discharge (average of 7 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start11 Nov 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurice M. Garcia, Cedars-Sinai Medical Center
- Investigators
- Maurice M Garcia, M.D., MAS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979338
- Sponsor's protocol ID
- STUDY00000879
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
- ClinicalTrials.gov ID
- NCT04979338
- Acronym / sponsor ID
- STUDY00000879
- Conditions
- Gender Dysphoria
- Keywords
- Gender Dysphoria, Gender-Affirming Surgery, Peri-Operative Pain, Pain Management, Surgery Pain, Sex Reassignment Surgery, Gender Reassignment Surgery, Vaginoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 | Active comparator | 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 anestheticDepending 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) |
| Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 | Active comparator | Drug: Bupivacaine, Other: Bilateral ultrasound guided Transversus Abdominis Plane Block, Other: Local anestheticDepending 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) |
| Surgery-specific general anesthetic + local anesthetic at incision site | Active comparator | Drug: Bupivacaine, Other: Bilateral spermatic cord block, Other: Local anestheticDepending 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided Continuous Infraclavicular Brachial Plexus Block20cc 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 | Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 |
| Ultrasound guided Continuous Femoral Nerve Block20cc 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 | Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 |
| Ultrasound guided Pudendal Nerve Block20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision] | Other | Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 |
| BupivacaineAlso: Marcaine0.25% or 0.5% with or without 1:200K epinephrine | Drug | Surgery-specific general anesthetic + local anesthetic at incision site, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 |
| Bilateral ultrasound guided Transversus Abdominis Plane Block40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery] | Other | Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 |
| Bilateral spermatic cord block10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop] | Other | Surgery-specific general anesthetic + local anesthetic at incision site, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 |
| Pecs I & II Block0.25% bupivacaine: 15-30mL per side for Pecs I-III | Other | Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 |
| Local anesthetic0.25% or 0.5% bupivacaine into the appropriate surgical site | Other | Surgery-specific general anesthetic + local anesthetic at incision site, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1, Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 |
Primary outcome
Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps
Time frame: 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)
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.
Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient
Time frame: 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)
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.
Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Recorded time to spontaneous voiding will be collected from hospital records.
Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire
Time frame: Pre-operative visit, Discharge (average of 7 days after surgery), and End of Study/final post-operative visit (average of 30 days after surgery)
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."
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
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.
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
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Recorded number of post-operative days and experience of nausea will be obtained from hospital records.
Post-operative length of inpatient stay
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery
Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory
Time frame: 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)
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).
Frequency of treatment complications
Time frame: End of study (average of 30 days after surgery)
Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.
3 secondary outcomes
Time to mobilization
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Time to first day of bowel movement
Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)
Number of participants with any hospital readmission within 30 days of discharge
Time frame: 30 days after Day of Discharge (average of 7 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maurice M Garcia, M.D., MAS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block and Ultrasound guided Pudendal Nerve Block in people with Gender Dysphoria, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Stelmar, BS (805-813-7882, jenna.stelmar@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.