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Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain

Study acronym: VPIA
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2025 → Dec 31, 2027
See other at-risk trials from KK Women's and Children's Hospital

Record History

  1. Primary and study completion pushed from Dec 31, 2025 to Dec 31, 2027v12
  2. Primary completion date: Dec 31, 2023 to Dec 31, 2025v11
  3. Study completion date: Dec 31, 2023 to Dec 31, 2025v10
  4. Primary completion date: Aug 31, 2022 to Dec 31, 2023v9
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 40
    • Study completion date: Dec 31, 2022 to Dec 31, 2023
    • Site details revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Dec 31, 2021 to Aug 31, 2022
    • Study sites: 0 to 1
    • Start date changed from estimate of May 31, 2021 to Mar 31, 2021
    v7
  2. Start date: Jan 31, 2021 to May 31, 2021
    • Primary completion date: Aug 31, 2021 to Dec 31, 2021
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    v6
  3. Start date: Sep 1, 2020 to Jan 31, 2021v5
  4. Start date: Jul 1, 2020 to Sep 1, 2020v4
  5. Primary completion date: Dec 31, 2020 to Aug 31, 2021
    • Start date: Dec 1, 2019 to Jul 1, 2020
    • Study completion date: Feb 28, 2021 to Dec 31, 2021
    v3
  6. Start date: Sep 1, 2019 to Dec 1, 2019v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To meet the unmet need of better and safer pain relief for acute pain in the post-operative setting, a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia ("VPIA") Delivery System, with novel and intelligent software algorithms and specialised hardware was developed. In the previous project, the investigators have shown that this system has the potential to increase the safety and patient satisfaction with intravenous opioid analgesia. However, opportunities to develop more robust vital signs monitoring with the goal of ensuring continual and effective analgesia are identified. The primary aim of this proposal is to advance the development of technology (through new features and functionality) and perform clinical evaluation of the VPIA system with a larger sample size to show improvements in patient's satisfaction (pain relief) and robustness of system in terms of vital signs integration. Novel technology using adaptive vital signs controller, integrated with an infusion pump and single finger probe vital signs monitor system will be developed with the aim for commercialisation.
Trial Details
NCT Number NCT04011163
Lead Sponsor KK Women's and Children's Hospital
Conditions
(from sponsor)		 Pain, Respiratory Depression
Related terms Hypoventilation, Pain, Postoperative Pain, Respiratory Insufficiency
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov