Maneuvers to Reduce Laparoscopic Pain

Официальное название

Optimal Maneuver to Reduce Postoperative Pain Following Elective Laparoscopic Surgeries

Обзор

Laparoscopic surgery has revolutionized surgical care by reducing morbidity and improving post operative recovery. Laparoscopic surgery involves the use of carbon dioxide for insufflation to achieve optimal visualization. There is literature that demonstrates higher insufflation pressures being associated with increased postoperative pain - particularly shoulder pain - and opioid use. The ideal amount of intraperitoneal pressure is still under debate as other studies demonstrate that reduced pneumoperitoneum insufflation has also shown to negatively impact surgeon satisfaction and trended with longer operative time and greater blood loss without impacting pain. Residual intraperitoneal carbon dioxide can also contribute to postoperative discomfort. Studies have shown the effectiveness of various maneuvers in removing residual gas to reduce postoperative pain, such as intraperitoneal saline instillation, pulmonary recruitment, and gas aspiration via smoke evacuator. Despite these advantages, there is a lack of a clear consensus on the optimal method for reducing residual intraperitoneal gas. Conversely, literature has mixed results regarding the true significance in pain reduction. Given the importance of minimizing postoperative pain, reducing opioid requirements, and shortening postoperative recovery time, the investigators propose a prospective, patient-blinded, randomized controlled trial. The investigators aim to investigate whether active gas removal via a smoke evacuator, multiple breath recruitment maneuvers, or no intervention would contribute to lowest postoperative pain. The findings will help identify the most effective method for reducing residual pneumoperitoneum-related pain and thus inform surgical practices and improve patient outcomes.

Вмешательства

• Процедура Smoke Evacuation Group
  Active gas removal via smoke evacuator for 30 seconds at the end of case.
• Процедура Recruitment Breath Group
  Repeated pulmonary inflation maneuvers: Three (3) consecutive manual ventilations at maximum of 30 cm water at the end of case.
• Процедура Control Group
  Passive desolation of the pneumoperitoneum at the end of the laparoscopic surgery.

Первичные конечные точки

• Post operative pain [Срок оценки: From enrollment until 1 week post surgery]

Вторичные конечные точки (1)

• Opioid use for the management of post operative pain [Срок оценки: Time of enrollment until their post operative appointment up to 2 weeks from the time of surgery]

Критерии участия

Критерии включения

• Patients age 18 to 65
• Benign, elective laparoscopic surgeries

Критерии исключения

• Ages <18 and age >65
• Emergency or urgent surgeries
• Surgeries for chronic pelvic pain, malignancy
• Surgeries during pregnancy
• Severe cardiopulmonary disease
• Prior extensive abdominal surgeries (more than 2 abdominal or pelvic surgeries)
• Inability to consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Henry Ford Hospital — Detroit

Идентификаторы

NCT: NCT07583433 · 18542-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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