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

NCT04011163 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-09

No results posted yet for this study

Summary

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.

Conditions

  • Pain
  • Respiratory Depression

Interventions

DEVICE

VPIA pump

The pump is a specially designed and manufactured infusion syringe pump for intravenous analgesia. It incorporates the VPIA study regimen to meet the specific requirements of the clinical trial. It is intended to be used only for delivering drugs intravenously.

DRUG

Morphine

Intravenous medication used is morphine diluted in normal saline to a concentration of 1mg/ml. This is a standard dilution and are routine drugs used as standard of care.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Ban Leong Sng, MBBS, MMED · KK Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011163 on ClinicalTrials.gov