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

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

Bilateral ultrasound guided Transversus Abdominis Plane Block

40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]

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

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.