Pain Management for Gender-Affirming Surgeries
This study is looking at different ways to manage pain after gender-affirming surgeries, aiming to reduce the need for opioid medications. It will compare standard pain treatments like bupivacaine (a local anesthetic) given through nerve blocks (Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block, Bilateral ultrasound guided Transversus Abdominis Plane Block). You may be able to join if you are 18 or older, identify as transgender, and are having certain gender-affirming surgeries. The study will measure changes in your pain, how much opioid medication you use, and how quickly you can urinate after surgery. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 640 participants. It compares different standard-of-care pain treatment options.
- What's involved
- You will have pain medications administered by an anesthesiologist at the start and end of surgery, and continuously after surgery. Your pain levels, opioid use, and urinary function will be monitored for up to 30 days after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in pain and opioid consumption for an average of 30 days after surgery. Urinary retention will be monitored from post-operative Day 1 to discharge (average of 7 days).
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Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maurice M Garcia, M.D., MAS · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Changes in peri-operative pain location and intensity over time, as measured by anatomic pain mapsAny 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 outpatientPer 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 voidingPost-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 QuestionnairePre-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 flatusPost-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 nauseaPost-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 stayPost-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 InventoryDaily, 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 complicationsEnd 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.