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Набор по приглашению NCT05753046

Laparoscopic TAP Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Фаза IV С лечением Prostate Cancer

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: Early TAP Block, Late TAP Block.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
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 →
Официальное название

Perioperative Laparoscopic Transversus Abdominis Plane Block During Robotic Assisted Laparoscopic Radical Prostatectomy for Improvement in Postoperative Pain

Обзор

Determine the impact of a laparoscopic-guided transversus abdominis plane (TAP) block timing (at initiation or conclusion of procedure) on the postoperative pain experience in patients following robot assisted laparoscopic radical prostatectomy (RALP).

Подробное описание

TAP block involves the use of a local anesthetic agent injected between the internal oblique and transversus abdominis muscles for the goal of pain relief. Often times these are performed under ultrasound guidance by the anesthesiology team preoperatively. The idea behind this is to provide a neurologic block to the sensory nerve fibers supplying the anterior abdominal wall, between the internal oblique and transversus abdominis muscles. More recently, this technique has been investigated in the setting of robot-assisted laparoscopic radical prostatectomy (RALP) with promising results. There is a lack of data comparing the benefits of the timing of TAP block, and whether performing this at the initiation versus conclusion of the case provides superior results

This is a prospective, randomized controlled trial of subjects undergoing early versus late TAP block for the management of postoperative pain following RALP. Subjects will be recruited through physician referral from private Urology offices. Potential subjects (patients scheduled for RALP procedure) will be approached by the study doctor prior to surgery, either in the study doctor's office or in the pre-operative area.

Subjects who meet all the eligibility criteria will be enrolled in the study and randomized (1:1) to receive early or late surgeon performed laparoscopic TAP block. Each patient will only receive one treatment (TAP block) either at the initiation or conclusion of his procedure.

For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone either at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port) or at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). Study doctors will use laparoscopic / robotic camera visual aid to confirm positioning between the internal oblique and transversus abdominis muscles for the goal of pain relief.

Вмешательства

  • Препарат Early TAP Block
    For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the initiation of the procedure (immediately following placement of the robotic / laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the in
  • Препарат Late TAP Block
    For treatment delivery, subjects will receive 60 mL of 0.25 percent ropivacaine with 4 mg of dexamethasone at the conclusion of the procedure (immediately proceeding removal of the robotic / laparoscopic camera port). The TAP block will be performed with 15 mL 2 finger breadths subcostal at the mid-clavicular line and then 15 mL at the level of the umbilicus along the mid-axillary line on each side. Laparoscopic / robotic camera will be used as a visual aid to confirm positioning between the int

Первичные конечные точки

  • Compare laparoscopic-guided TAP block timing (at initiation "early" or conclusion "late" of procedure) on the postoperative pain levels reported in patients following robot assisted laparoscopic radical prostatectomy (RALP). [Срок оценки: 24 hours after RALP]
Вторичные конечные точки (7)
  • Compare the effects of TAP Block timing on total opioid consumption [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the effects of TAP Block timing on hospital length of stay [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the effects of TAP Block timing on return of bowel function [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the effects of TAP Block timing on postoperative nausea/vomiting [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the effects of TAP Block timing on ambulation [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the effects of TAP Block timing on readmission for pain [Срок оценки: 7 days after RALP with TAP Block]
  • Compare the safety and tolerability of laparoscopic TAP block. [Срок оценки: 7 days after RALP with TAP Block]

Критерии участия

Критерии включения

  • Able to read, understand, and provide written, dated, informed consent prior to screening, complete study form(s) independently, comply with study protocol, and communicate with study personnel about clinically important information.
  • Men ≥ 18 years of age.
  • Pathologically confirmed diagnosis of prostate cancer
  • Scheduled for routine RALP

Критерии исключения

  • Chronic opioid use (daily for \>3 months)
  • Weight \<40 kilograms
  • Any condition that causes a lack of normal sensation to the abdomen or pelvis
  • Current or history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation

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
Двойное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Corewell Health William Beaumont University Hospital — Royal Oak

Идентификаторы

NCT: NCT05753046 · 2022-235

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗