Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology

Официальное название

Evaluation of One-hour Application of Abdominal Jackson-Pratt Drain in Order to Reduce Pain After Laparoscopic Surgery in Gynecology

Обзор

Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal and sub-diaphragmatic pain nerve fibers. The reduction of the residual pnemoperitoneum at the end of the surgical procedure could therefore play a key role in the reduction of post-operative pain, with consequent greater comfort for the patient and reduction of the use of analgesics. In view of the available evidence, the aim of the present study is to evaluate whether the application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can significantly reduce post-operative pain and the need of analgesics in patients undergoing laparoscopic gynecological surgery.

Подробное описание

Laparoscopy in gynecological surgery offers numerous advantages, such as the reduction of operative time, intra-operative blood loss, post-operative pain and the possibility of early hospital discharge and return to normal daily activities in a short time.

Despite these points arewidely validated in the literature, sometimes patients undergoing laparoscopy complain of abdominal pains (although slight in intensity and temporary) in the post-operative period. In some cases, the pain is characteristically irradiated at the shoulders, due to a probable irritation/compression of the phrenic nerve that runs on the lower surface of the diaphragm.

Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, the use of low pressures of carbon dioxide (CO2) for induction of the pnemoperitoneum has been associated with a reduction in post-operative pain, probably due to a lower abdominal distension and a consequent reduced compression of the pelvic, abdominal and sub-diaphragmatic pain nerve fibers.

The reduction of the residual pnemoperitoneum at the end of the surgical procedure could therefore play a key role in the reduction of post-operative pain, with consequent greater comfort for the patient and reduction of the use of analgesics.

In view of the available evidence, the aim of the present study is to evaluate whether the application of Jackson-Pratt drain, for one hour from the end of the surgical procedure, can significantly reduce post-operative pain and the need of analgesics in patients undergoing laparoscopic gynecological surgery.

Вмешательства

• Устройство abdominal Jackson-Pratt drain
  One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.

Первичные конечные точки

• Pain [Срок оценки: 6 hours after surgery.]

Вторичные конечные точки (3)

• Pain [Срок оценки: 12 hours after surgery.]
• Pain [Срок оценки: 24 hours after surgery.]
• Use of Analgesic [Срок оценки: During the 48 hours after surgery.]

Критерии участия

Критерии включения

• Patients affected by uterine fibroids, undergoing laparoscopic surgery;
• American Society of Anesthesiologists physical status classification I-II.

Критерии исключения

• inability to express pain;
• any concomitant diseases requiring upper abdominal surgery, such as cholecystectomy or adhesiolysis;
• laparoscopic procedures that were converted to open surgery;
• other causes of known pain;
• oncological cases;
• use of drugs for chronic pelvic pain or hormones in the previous 3 months (wash-out period);
• application of other drainages;
• intra- or post-operative complications.

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

Италия · 1 центр

• University of Insubria — Varese

Идентификаторы

NCT: NCT03440086 · DRAIN-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗