Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
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: TAP Anesthesia, Surgeon-Initiated Local Anesthetic.
- Кому может быть актуально
- Состояния в реестре: Analgesia, Surgery. Базовые параметры: от 18 лет · Женщины.
- 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 is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.
Подробное описание
Primary Objective
* To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy.
Secondary Objectives
* To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy. * To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy. * To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
Вмешательства
- Препарат TAP Anesthesia
ultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections - Препарат Surgeon-Initiated Local Anesthetic
266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound
Первичные конечные точки
- Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery [Срок оценки: 24 hours post-surgery]
Вторичные конечные точки (10)
- Mean postoperative pain score for the first 24 hours post-surgery [Срок оценки: 24 hours post-surgery]
- Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement [Срок оценки: estimated to be up to 3 days]
- Post-operative anti-emetic use [Срок оценки: estimated to be up to 3 days]
- Number of recorded episodes of emesis [Срок оценки: estimated to be up to 3 days]
- Return of bowel function measured in whole hours from completion of surgery to passage of flatus [Срок оценки: estimated to be up to 3 days]
- Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score [Срок оценки: post-operative visit (up to 60 days)]
- Readmission rate measured by readmission in the 30 days following surgery [Срок оценки: up to 30 days]
- Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay [Срок оценки: estimated to be up to 3 days]
- Summary of Post-operative Complications [Срок оценки: up to 30 days post-operatively]
- Time to First Ambulation measured in hours [Срок оценки: estimated to be within 72 hours post-surgery]
Критерии участия
Критерии включения
- Ability to understand and the willingness to sign a written informed consent document
- Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
- Patients must be >18 years old
- English speaking (able to provide consent and complete questionnaires)
- Patients must have the ability to understand visual and verbal pain scales
- Patients must be eligible for TAP block placement. This will be confirmed during preoperative visit with the primary surgeon. Patient's are not eligible if they have allergies to the anesthetic medications or have had prior abdominal reconstructive surgery that would alter their abdominal wall anatomy in a way where the block would not be expected to be effective.
Критерии исключения
- Known allergy to local anesthetics.
- Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
- Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
- Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
- Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
- Significant liver disease that would inhibit prescription of opioids.
- Significant kidney disease that would inhibit administration of gabapentin.
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- University of Wisconsin Hospitals and Clinics (UWHC) — Madison
Идентификаторы
NCT: NCT06213454 · 2023-1099 · UW23039 · NCI-2023-10464 · Protocol Version 7/17/2024 · A532820