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

Study acronym: DRAIN-1
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 2, 2022 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jun 1, 2023 to Jun 1, 2026
    • Start date: Jun 1, 2022 to Jun 1, 2025
    • Study completion date: Jun 15, 2024 to Jun 15, 2027
    v4
  2. Notable Primary completion date: Jun 1, 2022 to Jun 1, 2023
    • Start date: Jun 1, 2021 to Jun 1, 2022
    • Study completion date: Jun 15, 2023 to Jun 15, 2024
    v3
  3. Notable Primary completion date: Jun 1, 2019 to Jun 1, 2022
    • Start date: Jun 1, 2018 to Jun 1, 2021
    • Study completion date: Jun 15, 2019 to Jun 15, 2023
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03440086
Lead Sponsor Università degli Studi dell'Insubria
Conditions
(from sponsor)
Postoperative Pain
Related terms Pain, Postoperative Pain
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov