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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
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| 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:
|
|
| Surgery-specific general anesthetic + local anesthetic at incision site | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided Continuous Infraclavicular Brachial Plexus Block | Other | 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] |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Transgender persons
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Stelmar, BS | Contact | 805-813-7882 | jenna.stelmar@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Maurice M Garcia, M.D., MAS | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center - North and South Towers | Recruiting | Los Angeles | California | 90048 | United States |
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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:
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|
| Ultrasound guided Continuous Femoral Nerve Block | Other | 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 | Other | 20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision] |
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| Bupivacaine | Drug | 0.25% or 0.5% with or without 1:200K epinephrine |
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| Bilateral ultrasound guided Transversus Abdominis Plane Block | Other | 40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery] |
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| Bilateral spermatic cord block | Other | 10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop] |
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| Pecs I & II Block | Other | 0.25% bupivacaine: 15-30mL per side for Pecs I-III |
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| Local anesthetic | Other | 0.25% or 0.5% bupivacaine into the appropriate surgical site |
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| 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) |
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) |
| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003766 | Dental Occlusion |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003813 | Dentistry |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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