Vital-signs-integrated Patient-assisted Intravenous Opioid Analgesia
VPIAmorphine
1 other identifier
interventional
20
1 country
1
Brief Summary
This is a closed-loop system which is embodied in a novel and intelligent algorithm that takes into account patients' vital signs. The system allows better and responsive titration of personalized pain relief together with non-invasive physiological monitoring that measures oxygenation, breathing and heart rate continuously.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedStudy Start
First participant enrolled
December 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 9, 2024
October 1, 2024
5 months
February 28, 2016
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of episodes of breech in safety thresholds
Any episode of oxygen saturation \<95%, Heart rate \<60 bpm or Respiratory rate \<8 breaths/min
2 days
Secondary Outcomes (1)
Pain scores
2 or 3 days
Study Arms (1)
VPIA analgesia system
EXPERIMENTALVital-signs-integrated patient-assisted intravenous opioid analgesia system (VPIA). The vital signs (oxygen saturation, respiratory rate, heart rate) will be close monitored when patients is using VPIA pump. The drug used is intravenous morphine (1mg per milligram) with bolus of 1 mg.
Interventions
Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line with an anti-reflux valve to ensure precise drug administration and no backflow.
Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.
Eligibility Criteria
You may qualify if:
- Age 21-70 years old, female
- Healthy participants who are American Society of Anesthesiologists physical status 1 and 2 (with well controlled medical problems)
- Undergoing elective surgery with the intent of using postoperative PCA with morphine for postoperative analgesia
You may not qualify if:
- Allergy to morphine
- With significant respiratory disease and obstructive sleep apnea
- Unwilling to place oxygen saturation monitoring devices during study period
- Unable to comprehend the use of patient controlled analgesia
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, 229899, Singapore
Related Publications (1)
Sng BL, Tan DJ, Tan CW, Han NR, Sultana R, Sia ATH. A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain. BMC Anesthesiol. 2020 Jun 8;20(1):145. doi: 10.1186/s12871-020-01060-4.
PMID: 32513113DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ban L Sng, FANZCA
KK Women's and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2016
First Posted
June 17, 2016
Study Start
December 29, 2016
Primary Completion
May 30, 2017
Study Completion
December 31, 2025
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share