Идёт набор NCT04979338

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

Фаза III С лечением Gender Dysphoria

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block, Bupivacaine.
Кому может быть актуально: Состояния в реестре: Gender Dysphoria. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Другое 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 \[administered by anesthesiologist\]
Другое 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 \[administered by anesthesiologist\]
Другое Ultrasound guided Pudendal Nerve Block
20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]
Препарат Bupivacaine
0.25% or 0.5% with or without 1:200K epinephrine
Другое Bilateral ultrasound guided Transversus Abdominis Plane Block
40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]
Другое Bilateral spermatic cord block
10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
Другое Pecs I & II Block
0.25% bupivacaine: 15-30mL per side for Pecs I-III
Другое Local anesthetic
0.25% or 0.5% bupivacaine into the appropriate surgical site

Первичные конечные точки

Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
Post-operative length of inpatient stay [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: End of study (average of 30 days after surgery)]

Вторичные конечные точки (3)

Time to mobilization [Срок оценки: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
Time to first day of bowel movement [Срок оценки: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
Number of participants with any hospital readmission within 30 days of discharge [Срок оценки: 30 days after Day of Discharge (average of 7 days after surgery)]

Критерии участия

Критерии включения

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)